| 1 |
NCT02510560 |
Recruiting |
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants |
- Premature Birth of Newborn
- Intestinal Malabsorption
|
- Drug: NTRA-2112
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Numbers of days to achieve complete enteral feeding
- Number of days to achieve discharge from hospital or readiness to discharge
- Growth velocity (g/kg/day)
|
530 |
All |
up to 5 Days (Child) |
NCT02510560 |
FIT-04 |
|
December 2016 |
May 2019 |
August 2021 |
July 29, 2015 |
March 20, 2018 |
|
- Vidant Medical Center
Greenville, North Carolina, United States - University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States - Medical University of South Carolina
Charleston, South Carolina, United States - (and 47 more...)
|
| 2 |
NCT03270085 |
Recruiting |
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption |
- Chronic Diarrhea
- Irritable Bowel Syndrome With Diarrhea
- Bile Acid Malabsorption
|
- Drug: Colesevelam
- Other: Placebo
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Other
|
- Patients with IBS-D with increased bowel bile acid will be treated with colesevelam to determine if stool frequency and consistency improves via daily bowel diaries.
- Patients with IBS-D with increased bowel bile acid will be treated with colesevelam to determine if stool frequency and consistency improves via fecal bile acids.
|
45 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03270085 |
17-004639 |
|
December 7, 2017 |
July 20, 2018 |
July 20, 2018 |
September 1, 2017 |
December 11, 2017 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 3 |
NCT02590120 |
Recruiting |
Enteral Nutrition and Amino Acid Absorption |
|
- Dietary Supplement: Enteral nutrition
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Other
|
- Amino acid absorption profile
- Tolerance
- Nutritional status
- (and 3 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT02590120 |
12.02.FR.NHS |
PEPS |
February 2015 |
December 2017 |
December 2017 |
October 28, 2015 |
October 20, 2017 |
|
- CHU de Lille
Lille, France
|
| 4 |
NCT03412149 |
Not yet recruiting |
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass) |
|
- Procedure: Mini Gastric Bypass
- Procedure: Roux en Y Gastric Bypass
|
Interventional |
Not Applicable |
- University of Roma La Sapienza
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Gut Microbiota
- Glucagon - like peptide 1 (GLP-1)
|
90 |
All |
18 Years to 65 Years (Adult) |
NCT03412149 |
RG11715C7CE1AD8A |
|
February 19, 2018 |
August 19, 2018 |
August 19, 2019 |
January 26, 2018 |
January 26, 2018 |
|
|
| 5 |
NCT02849704 |
Recruiting |
Fat Malabsorption in Chronic Pancreatitis |
|
|
Interventional |
Phase 2 |
- Children's Hospital of Philadelphia
- AbbVie
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Phoenix Indian Medical Center
|
Other / Industry / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Difference in mean malabsorption blood test (MBT) between groups
|
48 |
All |
30 Years to 70 Years (Adult, Senior) |
NCT02849704 |
16-013001 |
|
July 2016 |
December 2018 |
December 2018 |
July 29, 2016 |
February 5, 2018 |
|
- Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
|
| 6 |
NCT03140371 |
Recruiting |
High Energy High Protein Peptide Feed Study |
- Malnutrition
- Malabsorption
|
- Dietary Supplement: High energy high protein peptide feed study
|
Interventional |
Not Applicable |
- Nutricia UK Ltd
- National Health Service, United Kingdom
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Gastro-intestinal tolerance (change is assessed at different timepoints)
- Compliance with feed prescription
- Acceptability
- (and 4 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT03140371 |
HEHP16 |
|
July 14, 2017 |
December 2019 |
December 2019 |
May 4, 2017 |
September 19, 2017 |
|
- Cumbria Partnership NHS Foundation Trust
Whitehaven, Cumbria, United Kingdom - Derby Teaching Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom - Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, United Kingdom - (and 7 more...)
|
| 7 |
NCT02628626 |
Recruiting |
A Study of Colesevelam in Fecal Incontinence |
- Fecal Incontinence
- Bile Acid Malabsorption
|
- Drug: Colesevelam
- Drug: Clonidine
- Other: Placebo
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percentage of patients who have a 50% reduction in the frequency of fecal incontinence (FI) episodes
- Change in the number of days with fecal incontinence
- Change in the volume of fecal incontinence
- (and 12 more...)
|
60 |
Female |
18 Years to 80 Years (Adult, Senior) |
NCT02628626 |
15-005986 |
|
November 2015 |
October 2018 |
October 2019 |
December 11, 2015 |
July 21, 2017 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 8 |
NCT02798718 |
Recruiting |
Whole Milk Intake and Cardio-metabolic Risk Factors |
- Lactose Malabsorption
- Cardiovascular Disease
|
- Dietary Supplement: full-fat milk
|
Interventional |
Not Applicable |
- Huazhong University of Science and Technology
|
Other |
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Changes in body weight
- Change in body composition (body fat mass and lean mass)
- Changes in blood pressure
- (and 10 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02798718 |
0214513214 |
|
May 2016 |
August 2016 |
|
June 14, 2016 |
June 27, 2016 |
|
- Huazhong University of Science and Technology
Wuhan, Hubei, China
|
| 9 |
NCT03438227 |
Not yet recruiting |
Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial |
- Iron Deficiency Anemia of Pregnancy
- Iron Malabsorption
|
- Drug: Iron dextran
- Drug: Ferrous sulfate 325mg
|
Interventional |
Phase 4 |
- Washington University School of Medicine
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Maternal outcome: hemoglobin on admission to inpatient obstetrics unit for delivery of infant
- Incidence of Medication Adverse events [Safety and Tolerability]
- Maternal outcome: hemoglobin on postpartum day #1
- (and 8 more...)
|
120 |
Female |
Child, Adult, Senior |
NCT03438227 |
201712110 |
IVIDA |
March 1, 2018 |
June 30, 2019 |
August 1, 2019 |
February 19, 2018 |
February 19, 2018 |
|
- Center for Outpatient Health, Washington University in St. Louis
Saint Louis, Missouri, United States
|
| 10 |
NCT03168555 |
Recruiting |
Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy |
- Bile Acid Malabsorption
- Cholelithiasis
|
- Drug: chenodeoxycholic acid
|
Interventional |
Phase 4 |
- Zealand University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Change in FGF19
- Change in CDCA absorption
- Change in C4
- (and 4 more...)
|
20 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03168555 |
SJ-434
2016-004692-53 |
BACH |
June 22, 2017 |
April 1, 2018 |
April 1, 2018 |
May 30, 2017 |
December 13, 2017 |
|
- Zealand University Hospital
Køge, Denmark
|
| 11 |
NCT02987569 |
Recruiting |
Teen and Young Adult Connections for Support From Multidisciplinary Professionals & Peers |
- Short Bowel Syndrome
- Malabsorption
- Malnutrition
|
- Behavioral: mConnect plus mobile connections to multidisciplinary professionals & peers
- Behavioral: iPad use plus one mobile connections to multidisciplinary professionals & peers
- Device: iPad
|
Interventional |
Not Applicable |
- University of Kansas Medical Center
- National Institute of Nursing Research (NINR)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Health Survey SF-12v2 (predicts future health services use).
- Quality of Life (Cantril Ladder)
- Beck Depression Inventory-II (BDI-II)
- (and 4 more...)
|
85 |
All |
13 Years to 30 Years (Child, Adult) |
NCT02987569 |
STUDY00004067
R01NR015743-01A1 |
|
July 2016 |
July 2019 |
December 2019 |
December 9, 2016 |
January 5, 2018 |
|
- University of Kansas Medical Center
Kansas City, Kansas, United States
|
| 12 |
NCT03492190 |
Not yet recruiting
New |
Bioavailability of Proteins From Plant Based Diets |
- Protein Malabsorption
- Nutrition Disorders
- Sarcopenia
|
|
Observational |
|
- Eduardo Ferriolli
- University of Sao Paulo
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Bioavailability protein using deuterium
- Bioavailability protein using carbon 13
- Nutritional composition
|
45 |
All |
18 Years to 65 Years (Adult) |
NCT03492190 |
2207 |
|
May 1, 2018 |
May 23, 2018 |
December 31, 2020 |
April 10, 2018 |
April 10, 2018 |
|
|
| 13 |
NCT02199496 |
Recruiting |
Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency |
- CVID
- Enteropathy
- Chronic Diarrhea
- (and 2 more...)
|
|
Interventional |
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint of the study is whether treatment with ustekinumab is safe and tolerated in CVID enteropathy patients and does not cause a significant increase in infection or result in any serious adverse events (SAEs) that are determined...
- The secondary endpoint of the study is whether patients respond to the treatment with ustekinumab. Response will be defined as <1% decrease in weight or a decrease in the number of stools at the Week 8, Week 16, Week 24, Week 32 and Week 40 v...
|
10 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02199496 |
140153
14-I-0153 |
|
July 23, 2014 |
December 31, 2018 |
December 31, 2019 |
July 24, 2014 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 14 |
NCT03401541 |
Not yet recruiting |
25-Hydroxyvitamin D Pharmacokinetic Study |
|
- Drug: Calcifediol
- Drug: Calciferol
|
Interventional |
Early Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change in Serum vitamin D status
- Change in 25-Hydroxyvitamin D Status
- Serum Calcium Levels
- (and 4 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03401541 |
H-37167 |
|
May 2018 |
June 1, 2018 |
December 31, 2018 |
January 17, 2018 |
April 9, 2018 |
|
- Dr. Solomon Carter Fuller Mental Health Center, 85 E Newton St M-1013
Boston, Massachusetts, United States
|
| 15 |
NCT03441581 |
Recruiting |
3030-401-002 ELX BAM Study |
- Irritable Bowel Syndrome With Diarrhea
|
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change from baseline in average Bristol Stool Form Scale (BSFS) score over 4 weeks of treatment period
- Percentage of Participants with Treatment Emergent Adverse Events
- Percentage of participants who experienced clinically significant change in Laboratory Tests
- (and 16 more...)
|
24 |
All |
18 Years to 65 Years (Adult) |
NCT03441581 |
3030-401-002 |
|
February 23, 2018 |
July 20, 2018 |
July 27, 2018 |
February 21, 2018 |
March 5, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 16 |
NCT03462979 |
Recruiting |
Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease |
- Celiac Disease
- Gluten Sensitivity
- Gluten Enteropathy
- (and 8 more...)
|
- Device: Immunochromatographic lateral flow test
|
Interventional |
Not Applicable |
- Boston Children’s Hospital
- Glutenostics, LLC
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Difference in frequency of gluten exposure in open results vs blinded groups following randomization.
- Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups
- Celiac disease symptom score in blinded vs. open results group at the end of the study
- (and 3 more...)
|
120 |
All |
6 Years to 18 Years (Child, Adult) |
NCT03462979 |
P00024698 |
|
April 15, 2018 |
December 31, 2021 |
December 31, 2023 |
March 13, 2018 |
April 20, 2018 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
| 17 |
NCT02953223 |
Recruiting |
A Study to Monitor the Use of an Amino Acid-Based Infant Formula |
- Cow's Milk Protein Allergy
- Eosinophilic Gastrointestinal Disorders
- Malabsorption/Maldigestion
- (and 2 more...)
|
- Other: Free amino acid infant formula
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Adverse events
- Clinical characteristics
|
20 |
All |
up to 12 Months (Child) |
NCT02953223 |
15.04.US.HCN |
EAGLE |
January 2017 |
June 2018 |
June 2018 |
November 2, 2016 |
January 26, 2018 |
|
- Pediatric Multicare West
Lakeside, Arizona, United States - Phoenix Children's Hospital
Phoenix, Arizona, United States - University of Arizona
Tucson, Arizona, United States - (and 26 more...)
|
| 18 |
NCT01967849 |
Recruiting |
Prevalence of Carbohydrate Intolerance in Lean and Overweight/Obese Children |
|
- Diagnostic Test: Oral Glucose tolerance test
|
Interventional |
Not Applicable |
- Yale University
- National Institutes of Health (NIH)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Glucose Tolerance
- Insulin resistance
|
2000 |
All |
7 Years to 21 Years (Child, Adult) |
NCT01967849 |
11190
R01HD040787 |
|
September 1999 |
September 2021 |
September 2021 |
October 23, 2013 |
December 7, 2017 |
|
- Yale University
New Haven, Connecticut, United States
|
| 19 |
NCT02551289 |
Recruiting |
MAgnetic Resonance Imaging in COeliac Disease |
- Celiac Disease
- Coeliac Disease
- Celiac Sprue
- Gluten Enteropathy
|
|
Observational |
|
- University of Nottingham
- Nottingham University Hospitals NHS Trust
- University of Salerno
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Fasting small bowel water content (SBWC)
- Colon volume
- Gut transit time
|
72 |
All |
18 Years to 65 Years (Adult) |
NCT02551289 |
14MP002 |
MARCO |
January 2016 |
September 2018 |
September 2019 |
September 16, 2015 |
October 25, 2017 |
|
- NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham
Nottingham, United Kingdom
|
| 20 |
NCT01893775 |
Recruiting |
Antibody Treatment for Advanced Celiac Disease |
- Celiac Disease
- Celiac Sprue
- Gluten Enteropathy
- Gluten-Sensitive Enteropathy
|
- Biological: Hu-Mik- Beta-1
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
- Mayo Clinic
- National Institutes of Health Clinical Center (CC)
|
NIH / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- safety of Hu MIK Beta 1 in celiac disease pts
|
12 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT01893775 |
999913148
13-C-N148 |
|
June 12, 2013 |
June 3, 2020 |
June 3, 2021 |
July 9, 2013 |
March 2, 2018 |
|
- Mayo Clinic, Rochester
Rochester, Minnesota, United States
|
| 21 |
NCT03486990 |
Recruiting
New |
Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease |
|
|
Interventional |
Phase 1 |
- Cour Pharmaceutical Development Company, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 as a Measure of Safety and Tolerability of TIMP-GLIA
- Pharmacokinetics of TIMP-GLIA in plasma: Cmax
- Pharmacokinetics of TIMP-GLIA in plasma: Tmax
- (and 5 more...)
|
22 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03486990 |
TGLIA-5.001 |
|
February 9, 2018 |
November 2018 |
March 2019 |
April 3, 2018 |
April 10, 2018 |
|
- Jacksonville Center For Clinical Research
Jacksonville, Florida, United States - Mass General Hospital Translational and Clinical Research Centers
Boston, Massachusetts, United States - Mayo Gastroenterology Research Unit
Rochester, Minnesota, United States - Prism Clinical Research
Saint Paul, Minnesota, United States
|
| 22 |
NCT03409796 |
Not yet recruiting |
Assessment of Immune Activation and Tolerance in Celiac Disease |
|
- Dietary Supplement: Gluten
|
Interventional |
Early Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Change From Baseline in Small Intestine Histology
- Correlation Coefficient Between Gluten-specific Blood T Cells and Standard CeD Histological Assessments
- Change From Baseline in Blood T Cells After Gluten Challenge
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03409796 |
TIMP-GLIA-5001
U1111-1202-6708 |
|
April 24, 2018 |
January 28, 2019 |
January 28, 2019 |
January 24, 2018 |
April 17, 2018 |
|
|
| 23 |
NCT03321214 |
Not yet recruiting |
Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease |
|
- Device: Gluten Sensor Device
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Quality of life measure
- Depression
- Adherence to the gluten-free diet
- (and 2 more...)
|
30 |
All |
13 Years to 65 Years (Child, Adult) |
NCT03321214 |
AAAR6004 |
|
December 1, 2017 |
June 1, 2018 |
December 1, 2018 |
October 25, 2017 |
October 30, 2017 |
|
- Celiac Disease Center at Columbia University
New York, New York, United States
|
| 24 |
NCT03271138 |
Recruiting |
Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms |
|
- Dietary Supplement: Bifidobacterium infantis NLS super strain (Natren LIFE START®2)
- Other: Placebo
|
Interventional |
Phase 2 |
- Global Institute of Probiotics
- Dr. C. Bonorino Udaondo Gastroenterology Hospital
- Research Institute, Universidad del Salvador
- Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Changes in Gastrointestinal Symptom Rating Scale (GSRS)
- Changes in Celiac Symptoms Index (CSI)
- Changes in Quality of Life: SF-36
- (and 4 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03271138 |
GlobalIP
001 |
|
August 2017 |
September 2018 |
September 2018 |
September 1, 2017 |
September 1, 2017 |
|
- Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
Buenos Aires, Argentina
|
| 25 |
NCT03244254 |
Not yet recruiting |
Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients |
- Celiac Disease in Children
|
|
Observational |
|
- Schneider Children's Medical Center, Israel
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- I-FABP levels at diagnosis
- I-FABP levels during remission
|
70 |
All |
up to 17 Years (Child) |
NCT03244254 |
SchneiderCMCIsraelIFABP |
|
November 2017 |
August 2019 |
August 2020 |
August 9, 2017 |
October 4, 2017 |
|
- Schneider Children's Medical Center of Israel
Petaẖ Tiqwa, Israel
|
| 26 |
NCT03168490 |
Recruiting |
In Vivo Effects of the Gluten Friendly Bread in Coeliac Disease |
|
- Dietary Supplement: Gluten Friendly bread
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD
- The modulation of the gut microbiota by gluten friendly bread
|
60 |
All |
20 Years to 80 Years (Adult, Senior) |
NCT03168490 |
LSC 15/146 |
|
February 1, 2016 |
January 20, 2018 |
April 1, 2018 |
May 30, 2017 |
May 30, 2017 |
|
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom
|
| 27 |
NCT03136731 |
Recruiting |
Evidence-based Screening Strategies for Celiac Disease |
|
- Diagnostic Test: Celiac disease antibody screening
|
Observational |
|
- Katri Kaukinen
- Tampere University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Forthcoming celiac disease diagnosed by current diagnostic criteria
|
3517 |
All |
6 Months to 100 Years (Child, Adult, Senior) |
NCT03136731 |
Celiac2017 |
|
November 29, 2017 |
December 31, 2022 |
December 31, 2032 |
May 2, 2017 |
November 30, 2017 |
|
- Tampere University Hospital / Tampere University
Tampere, Finland
|
| 28 |
NCT03095573 |
Recruiting |
Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease |
|
- Device: Lateral-viewing CapsoCam device
- Device: Axial-viewing capsule
|
Interventional |
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- IRCCS Policlinico S. Donato
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Lesions detected
- Extension of the lesions
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT03095573 |
Capsocam |
|
March 1, 2017 |
October 31, 2018 |
February 28, 2019 |
March 29, 2017 |
March 30, 2017 |
|
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, MI, Italy - Irccs Policlinico San Donato
San Donato Milanese, MI, Italy
|
| 29 |
NCT03011931 |
Recruiting |
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568] |
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Compare simvastatin metabolism with intestinal biopsies
- Villous height and crypt depth
- Dietary interview
- (and 3 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03011931 |
15-007568 |
|
March 2016 |
December 2018 |
March 2019 |
January 6, 2017 |
March 21, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 30 |
NCT02946827 |
Recruiting |
A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms |
|
- Dietary Supplement: Balanced low FODMAPs /gluten free diet
- Dietary Supplement: Balanced gluten free diet
|
Interventional |
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.
- Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
- Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
- (and 2 more...)
|
68 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02946827 |
2016/464 |
|
January 2016 |
November 2016 |
January 2017 |
October 27, 2016 |
October 27, 2016 |
|
- University of Milan
Milan, Italy
|
| 31 |
NCT02805816 |
Not yet recruiting |
Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Diagnosis of Celiac Disease based on histological findings.
|
200 |
All |
6 Months to 18 Years (Child, Adult) |
NCT02805816 |
0466-15 RMC |
|
June 2016 |
June 2017 |
June 2018 |
June 20, 2016 |
June 20, 2016 |
|
- Schneider children's medical center of Israel
Petach-Tikva, Israel
|
| 32 |
NCT02764931 |
Not yet recruiting |
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1 |
- Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
|
- Other: Gluten free oats and gastrointestinal health
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Basic Science
|
- Pressure, temperature and pH in the intestinal tract
- Gastrointestinal symptoms (self-reported)
|
15 |
All |
18 Years to 65 Years (Adult) |
NCT02764931 |
KAURA1 |
|
August 2017 |
December 2018 |
December 2019 |
May 6, 2016 |
May 31, 2017 |
|
- Department of Biochemistry, University of Turku
Turku, Finland
|
| 33 |
NCT02761785 |
Recruiting |
Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2 |
- Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Fecal microbiota composition
- Metabolic status
|
60 |
All |
15 Years to 65 Years (Child, Adult) |
NCT02761785 |
KAURA2 |
|
May 29, 2017 |
December 2018 |
December 2019 |
May 4, 2016 |
May 31, 2017 |
|
- Department of Biochemistry, University of Turku
Turku, Finland
|
| 34 |
NCT02690532 |
Recruiting |
Gut Permeability Assessment in Celiac and Gluten Sensitive Children |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
60 |
All |
2 Years to 17 Years (Child) |
NCT02690532 |
15-006018 |
|
March 2016 |
October 2018 |
June 2019 |
February 24, 2016 |
August 17, 2017 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
| 35 |
NCT02475369 |
Recruiting |
Pancreatic Enzyme Supplementation for Celiac Disease |
|
|
Interventional |
Phase 4 |
- Beth Israel Deaconess Medical Center
- Actavis Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- reduction of gastrointestinal symptoms
- fecal elastase measurement
|
40 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02475369 |
2014P000375 |
|
May 2015 |
June 2019 |
December 2019 |
June 18, 2015 |
August 2, 2017 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
| 36 |
NCT02464150 |
Recruiting |
Gluten Challenge in Celiac Disease |
|
- Dietary Supplement: Gluten challenge
|
Interventional |
Not Applicable |
- Oslo University Hospital
- Stiftelsen Helse og Rehabilitering
- Helse Sor-Ost
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Transcriptome of gluten-specific T cells
|
10 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02464150 |
2013/1237 |
|
April 1, 2017 |
April 2018 |
June 2018 |
June 8, 2015 |
May 30, 2017 |
|
- Oslo university hospital - Rikshospitalet
Oslo, Norway
|
| 37 |
NCT02389062 |
Recruiting |
Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients |
- Adult Form of Celiac Disease
|
- Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.
|
Interventional |
Not Applicable |
- Thomas Jefferson University
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- 1) Change in the patient estimated gluten intake after administration of study pills using the Celiac Dietary Adherence Test (CDAT), to be assessed at the end of follow up week 12
- 2) Change in the Celiac disease symptoms, using the Celiac Symptom Index (CSI) after administration of study pills; to be assessed at the end of follow up week 12
- 3)Change in IgA antibody to tissue transglutaminase (IgA-TTG) levels after administration of study pills, to be assessed at the end of follow up week 12.
- (and 4 more...)
|
36 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02389062 |
14D.389 |
|
February 2015 |
February 2017 |
February 2019 |
March 17, 2015 |
March 17, 2015 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
| 38 |
NCT02242123 |
Recruiting |
Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay. |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Changes in the intestinal histology of the patients with clinically suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG antibodies, at the time of the first evaluation.
- Serum IgA anti-tTG antibodies evaluation.
- Symptoms/signs evaluation.
|
50 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02242123 |
ACPM05 |
|
January 2012 |
December 2016 |
June 2018 |
September 16, 2014 |
October 25, 2017 |
|
- Internal Medicine Department of the Hospital of Sciacca (Agrigento)
Sciacca, Agrigento, Italy - Internal Medicine Department of the University Hospital of Palermo
Palermo, Italy
|
| 39 |
NCT02202681 |
Recruiting |
Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule |
|
|
Interventional |
Phase 1 |
- Massachusetts General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Tolerability of OFDI Imaging in subjects swallowing the OFDI capsule
- Feasibility of OFDI Imaging in subjects swallowing the OFDI capsule
|
24 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02202681 |
2013-P-001405 |
|
August 2013 |
October 2018 |
October 2018 |
July 29, 2014 |
January 25, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 40 |
NCT02061306 |
Recruiting |
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study |
|
|
Observational |
|
- Massachusetts General Hospital
- University of Roma La Sapienza
- Università Politecnica delle Marche
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in composition of the microbiota of CD in at-risk infants using culture-independent high-throughput sequence analysis of the 16S rRNA genes using the Illumina sequencing platform.
- Change in gut permeability measured by serum zonulin levels and loss of gluten tolerance measured by increased expression of pro-inflammatory cytokines and appearance of anti-tTg antibodies.
|
400 |
All |
up to 6 Months (Child) |
NCT02061306 |
2013P001965 |
CDGEMM |
March 2014 |
December 2024 |
December 2024 |
February 12, 2014 |
September 14, 2016 |
|
- Massachusetts General Hospital for Children
Boston, Massachusetts, United States - University of Roma La Sapienza
Rome, Italy
|
| 41 |
NCT02713243 |
Recruiting |
To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. |
- Primary Bile Acid Diarrhea
|
- Drug: LJN452
- Drug: Placebo to LJN452
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of patients reported with adverse events , serious adverse events and death.
- Change from baseline in stool frequency
- Change from baseline in stool types
- (and 4 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02713243 |
CLJN452X2202
2015-003192-30 |
|
April 2016 |
September 2017 |
September 2017 |
March 18, 2016 |
November 11, 2016 |
|
- Novartis Investigative Site
Rochester, Minnesota, United States - Novartis Investigative Site
Heidelberg, Germany - Novartis Investigative Site
London, United Kingdom - Novartis Investigative Site
Sheffield, United Kingdom
|
| 42 |
NCT01172665 |
Recruiting |
Celiac Disease Database |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
|
|
3500 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT01172665 |
16103A |
|
September 2008 |
September 2017 |
|
July 30, 2010 |
August 31, 2016 |
|
- The University of Chicago Medical Center
Chicago, Illinois, United States
|
| 43 |
NCT02895438 |
Recruiting |
Non Coeliac Gluten Sensitivity in Children |
- Diet, Gluten-Free
- Gluten-Sensitive Enteropathy
|
- Dietary Supplement: gluten
|
Interventional |
Not Applicable |
- Centre Hospitalier Universitaire de Saint Etienne
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Diagnostic
|
- Severity of IBS
- change in gastro-intestinal symptoms
- Change in quality of life
|
100 |
All |
6 Years to 16 Years (Child) |
NCT02895438 |
1408204 |
|
April 2014 |
October 2017 |
February 2018 |
September 9, 2016 |
January 23, 2017 |
|
- CHU Saint-Etienne
Saint-Etienne, France
|
| 44 |
NCT03371862 |
Recruiting |
Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS) |
|
- Drug: Liraglutide Pen Injector [Victoza]
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improvement in parenteral support
- Improvement in quality of life
- Duration of response
- (and 2 more...)
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT03371862 |
17IC3834 |
SLIPS |
October 28, 2017 |
August 30, 2018 |
September 30, 2018 |
December 13, 2017 |
December 13, 2017 |
|
- St Mark's Hospital
Harrow, United Kingdom
|
| 45 |
NCT02929316 |
Not yet recruiting |
Vedolizumab Induction May Prevent Celiac Enteritis |
|
|
Interventional |
Phase 2 |
- AGA Clinical Research Associates, LLC
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Normal histopathology following induction dosing with vedolizumab
- Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange
|
10 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02929316 |
IISR-2016-101481 |
|
October 2016 |
October 2017 |
December 2017 |
October 11, 2016 |
October 11, 2016 |
|
- AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States - Theresa Stevens
Egg Harbor Twp, New Jersey, United States
|
| 46 |
NCT01946503 |
Recruiting |
Infant & Toddler Short Gut Feeding Outcomes Study |
- Short Bowel Syndrome
- Intestinal Failure
- Home Parenteral Nutrition
|
|
Observational |
|
- Children's Hospital Los Angeles
|
Other |
- Observational Model: Case-Only
- Time Perspective: Retrospective
|
- Retrospective data
- Validated Questionnaires
|
40 |
All |
3 Months to 6 Years (Child) |
NCT01946503 |
CCI-13-00053 |
|
April 2013 |
December 2018 |
July 2019 |
September 19, 2013 |
January 23, 2018 |
|
- Children's Hospital Los Angeles
Los Angeles, California, United States
|
| 47 |
NCT02203201 |
Recruiting |
Diagnostic Significance of Positive EmA Antibodies in the Duodenal Culture Medium of Not-Celiac Wheat Sensitivity (NCWS) |
- Not-celiac Gluten Sensitivity
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Changes in the intestinal histology of NCWS patients who tested positives for EmAs in the culture medium of the intestinal biopsies, at the time of the first evaluation.
- Serum anti-tTG antibodies evaluation.
- Serum DPG antibodies evaluation.
- (and 3 more...)
|
50 |
All |
18 Years to 65 Years (Adult) |
NCT02203201 |
ACPM04 |
NCWS |
January 2014 |
October 2016 |
June 2018 |
July 29, 2014 |
October 25, 2017 |
|
- Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, Italy - Department of Internal Medicine, University Hospital of Palermo
Palermo, Italy
|
| 48 |
NCT01762579 |
Recruiting |
Bio-markers of Not-celiac Wheat Sensitivity |
- Not-celiac Wheat Sensitivity
|
- Dietary Supplement: wheat flour
- Dietary Supplement: Xylose
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Symptoms/signs evaluation
- Bio-Markers evaluation
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT01762579 |
ACPM03 |
|
January 2012 |
December 2016 |
June 2018 |
January 7, 2013 |
October 25, 2017 |
|
- Internal Medicine, "Giovanni Paolo II" Hospital
Sciacca, Agrigento, Italy - Internal Medicine, University Hospital
Palermo, Italy
|
| 49 |
NCT03434639 |
Not yet recruiting |
Fluorescence Spectroscopy for Gut Permeability Assessment |
- Development and Validation of Gut Permeability Sensor
- Permeability; Increased
- Celiac Disease
- (and 3 more...)
|
- Diagnostic Test: Spectroscopic gut permeability test
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Blood concentration from intravenous injection
- Blood concentration from samples
- PEG permeability assay
- Histology
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03434639 |
18SM4374 |
GutPerm |
April 2018 |
September 2021 |
September 2021 |
February 15, 2018 |
February 15, 2018 |
|
|
| 50 |
NCT03351972 |
Recruiting |
Differences in Preparation for Small Bowel Capsule Endoscopy |
- Capsule Endoscopy
- Inflammatory Bowel Diseases
- Celiac Disease
|
- Drug: Klean Prep
- Other: Clear liquids only
|
Interventional |
Phase 4 |
- Sheffield Teaching Hospitals NHS Foundation Trust
- Hotel Dieu Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Other
|
- Clinician assessed Visual Quality of small bowel
- clinician assessed Diagnostic yield during capsule endoscopy
|
230 |
All |
18 Years and older (Adult, Senior) |
NCT03351972 |
STH20061 |
|
November 23, 2017 |
November 1, 2019 |
December 1, 2019 |
November 24, 2017 |
February 7, 2018 |
|
- Hotel Dieu Hospital
Kingston,, Ontario, Canada - Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
|
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