Dietary Triggers of Gastrointestinal Symptoms in IBS Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Irritable Bowel Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Participants will be required to be on a gluten-free diet for a period of 3 weeks before starting the study. Participants will then be randomized to take muesli bars containing either purified gluten, non-purified gluten with amylase trypsin inhibitors, or nocebo for 1 week followed by 2 weeks of washout, and then repeated for the two remaining dietary challenges so that at the end all participants have been on all dietary challenges. At the beginning and end of each challenge period, participants will visit the clinic to be evaluated for changes in IBS symptoms.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The statistician will also be masked from the treatments.Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Irritable bowel syndrome (IBS) is a heterogenous, common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits. Many IBS patients report symptom relief on a gluten-free diet (GFD), but it is uncertain whether gluten is the true culprit. The gluten-containing grai...
Irritable bowel syndrome (IBS) is a heterogenous, common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits. Many IBS patients report symptom relief on a gluten-free diet (GFD), but it is uncertain whether gluten is the true culprit. The gluten-containing grains wheat, rye, and barley all contain amylase-trypsin inhibitors (ATIs), and a GFD is virtually ATI-free. This double-blinded crossover randomized controlled trial aims to determine which IBS patients are affected by pure gluten and which are affected by gluten combined with ATIs. IBS patients who respond to and have been on a GFD for 3+ weeks will be randomized to receive a dietary challenge of muesli bars containing either 1) pure gluten, 2) non-purified gluten (containing ATIs), 3) or nocebo for a week followed by a 14 day washout. This will be repeated until all participants have had each dietary challenge. The study will evaluate the effects and potential mechanisms of purified and non-purified gluten on intestinal and extra-intestinal symptoms in IBS. It is likely that some IBS patients respond to gluten, while others respond to gluten combined with ATIs. Thus, this project may lead to better diagnosis and individualized dietary treatments for IBS.
Tracking Information
- NCT #
- NCT03664531
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Premysl Bercik, MD McMaster University Study Director: Maria Ines Pinto-Sanchez, MD McMaster University
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