Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03798249
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief Summary:
The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms, gut microbiota and cortisol levels in NCGS patients.

Condition or disease Intervention/treatment Phase
NCGS Gluten Other: Gluten Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: single-blinded, randomised - controlled, crossover
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Gluten
Patients will receive acutely 16 g of gluten and 2 muffins glutenfree with 8 g of gluten, twice a day, during 5 days
Other: Gluten
Tereos

Placebo Comparator: Placebo
Patients will receive acutely 16 g of whey protein and 2 glutenfree muffins, twice a day, during 5 days
Other: Placebo
Nestlé Health Science




Primary Outcome Measures :
  1. The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Positive and Negative Affect Schedule [ Time Frame: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) ]
    Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'

  2. The effect of gluten acutely and sub-acutely on extraintestinal symptoms in NCGS patients measured on the Profile of Mood State [ Time Frame: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) ]
    Scores are measured on the Visual Analogue Scale. Change from baseline. The scale is ranged 0 - 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 21, day 36 and day 41.


Secondary Outcome Measures :
  1. The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in NCGS patients measured on the visual analogue scale for gastrointestinal symptoms [ Time Frame: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 35), after test visit 4 (at day 40) ]
    With '0' no complaints and '10' a lot of complaints (change from baseline). Measured on the Visual Analogue Scale. Measured at day 0, day 15, day 21, day 36 and day 41.

  2. Effect of acute and sub-acute gluten administration on intestinal permeability (lactulose mannitol ratio) [ Time Frame: At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) ]
    Change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography at day 0, day 15, day 21, day 36 and day 41.

  3. Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in bloodsample [ Time Frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) ]
    Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41

  4. Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in bloodsample [ Time Frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) ]
    Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41

  5. Effect of acute and sub-acute gluten administration on lipopolysaccharide levels in bloodsample [ Time Frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) ]
    Change in lipopolysaccharide levels measured at day 0, day 21 and day 41

  6. Effect of acute and sub-acute gluten administration on gut microbiota composition [ Time Frame: After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 ]
    Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli (stool samples)

  7. Effect of acute and sub-acute gluten administration on cortisol awakening response [ Time Frame: Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41) ]
    Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-coeliac gluten sensitivity patients

    • Previous symptoms of IBS fulfilling Rome III criteria that self reportedly improved with a gluten-free diet
    • Symptoms currently well controlled on a gluten-free diet
    • Adherence to the gluten-free diet for at least 6 weeks prior to recruitment
    • Coeliac disease excluded (either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten-containing diet in individuals expressing the HLA-DQ2 or HLA-DQ8 haplotype)
    • IgA anti-tissue-transglutaminase or IgG anti-deaminated gliadin peptide positive
  • Body Mass Index (BMI) of 20 - 25 kg/m2
  • Stable body weight for at least 3 months prior to the start of the study

Exclusion Criteria:

  • Medical

    • Coeliac disease
    • Abdominal or thoracic surgery. Exception: appendectomy
    • Gastrointestinal, endocrine or neurological diseases
    • Cardiovascular, respiratory, renal or urinary diseases
    • Hypertension
    • Food or drug allergies
  • Psychiatric disorders

    • Eating disorders
    • Depressive disorders
    • Anxiety disorders
    • Psychotic disorders
  • Restraint or emotional eating
  • Medication on a regular basis, exception: oral contraception
  • History of cannabis use or any other drug of abuse for at least 12 months prior to the study
  • Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
  • Pregnant or breastfeeding women

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): NCT03798249


Locations
Layout table for location information
Belgium
TARGID Recruiting
Leuven, Vlaams-Brabant, Belgium
Contact: Annelies Geeraerts    016377034    Annelies.Geeraerts@kuleuven.be   
Jan Tack Recruiting
Leuven, Belgium, 3000
Contact: Jan Tack    498797124    jan.tack@med.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Layout table for additonal information
Responsible Party: Prof Dr Jan Tack, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03798249    
Other Study ID Numbers: S60127
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Immune System Diseases