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

NCT03869359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-10-22

No results posted yet for this study

Summary

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

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).

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).

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Magnus Simrén, MD, PhD · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869359 on ClinicalTrials.gov