The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-01

Brief Summary

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Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.

To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (\>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.

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Detailed Description

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The study is a randomized, double-blind, placebo-controlled, cross-over trial.

The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.

IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.

Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and VSI.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, Double-blind, Placebo-controlled, Cross-over Trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

The randomization was done by employees of the hospital that were otherwise not involved in the study by drawing concealed envelops. The interventions were concealed plastic bags marked A or B.

Study Groups

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Group A

Gluten-free diet with placebo powder vs Gluten-free diet with gluten powder

Group Type EXPERIMENTAL

Gluten-free diet with gluten powder

Intervention Type OTHER

The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Gluten-free diet with placebo powder

Intervention Type OTHER

The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Group B

Gluten-free diet with gluten powder vs Gluten-free diet with placebo powder

Group Type EXPERIMENTAL

Gluten-free diet with gluten powder

Intervention Type OTHER

The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Gluten-free diet with placebo powder

Intervention Type OTHER

The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Interventions

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Gluten-free diet with gluten powder

The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Intervention Type OTHER

Gluten-free diet with placebo powder

The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients with IBS according to Rome IV criteria

Exclusion Criteria

* allergy or documented intolerance to food,
* severe cardiovascular, hepatic, neurological or psychiatric disease
* serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (IBD),
* diabetes
* bowel dysfunction related to previous surgery
* pregnant or lactating women
* usage of antibiotics within 4 weeks before inclusion
* strict avoidance of foods

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes