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Trial record 51 of 200 for:    gastroenterology | Recruiting Studies | United States

Gut Permeability, Sensitivity and Symptomatology (GPSS)

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ClinicalTrials.gov Identifier: NCT02358564
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : September 15, 2017
Sponsor:
Collaborators:
University of Erlangen-Nürnberg
Heidelberg University
Information provided by (Responsible Party):
Lesley A. Houghton, Mayo Clinic

Brief Summary:
To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of IBS.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Visceral Hypersensitivity Procedure: Gastrointestinal Permeability Test Procedure: Upper Endoscopy Procedure: Rectal Barostat and Infusion of Fats Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gut Permeability, Sensitivity and Symptomatology: Is There a Link and Explanation for Exacerbation of Symptoms Post Meals
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Healthy Volunteers Procedure: Gastrointestinal Permeability Test
This test will involve ingesting a solution followed by urinalysis
Procedure: Upper Endoscopy
You will have an upper endoscopy
Procedure: Rectal Barostat and Infusion of Fats
Feeding tube will be placed as well as a small balloon in the rectum
Experimental: Irritable Bowel Syndrome Patients Procedure: Gastrointestinal Permeability Test
This test will involve ingesting a solution followed by urinalysis
Procedure: Upper Endoscopy
You will have an upper endoscopy
Procedure: Rectal Barostat and Infusion of Fats
Feeding tube will be placed as well as a small balloon in the rectum



Primary Outcome Measures :
  1. Mean Percent of complete epithelial cell loss [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Age 18 to 70 years
  • No restrictions on Hospital Anxiety and Depression score
  • No abdominal surgery (except appendectomy).
  • Written informed consent

Exclusion criteria

  • Females who are pregnant, breastfeeding or hysterectomized.
  • Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
  • Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
  • Use of oral corticosteroids within the previous 6 weeks
  • Ingestion of artificial sweeteners such as Splenda TM (sucralose), Nutrasweet TM (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
  • Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
  • Proton pump inhibitors.
  • Antibiotics for the preceding 60 days before the start of the study.
  • (vii) Alcohol intake beyond the recommended safe limit (<21 unites per week)
  • Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
  • Known allergy to fluorescein
  • Inflammatory bowel diseases, celiac disease.
  • Clinically significant bradycardia with potential to interfere with procedure induced vagal tone (Investigators may be guided by a cut-off heart rate of < 50

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358564


Contacts
Contact: Madhusudan Grover, MD Grover.Madhusudan@mayo.edu
Contact: Margaret Breen-Lyles 5072666332 breen-lyles.margaret@mayo.edu

Locations
United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kenneth DeVault, MD    904-953-8101    DeVault.Kenneth@mayo.edu   
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States
Contact: Madhusudan Grover, MD       Grover.Madhusudan@mayo.edu   
Contact: Margaret Breen-Lyles    5072666332    breen.lyles.margaret@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
University of Erlangen-Nürnberg
Heidelberg University
Investigators
Principal Investigator: Lesley Houghton, PhD Mayo Clinic

Responsible Party: Lesley A. Houghton, PhD, FSB, RFF, FACG, AGAF, Professor of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02358564     History of Changes
Other Study ID Numbers: 14-000837
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Lesley A. Houghton, Mayo Clinic:
IBS
Irritable Bowel Syndrome
Visceral Hypersensitivity
Permeability
Small Bowel
Lactulose
Mannitol

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Hypersensitivity
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases