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

NCT03869359 | Completed

• 1 other identifier: 627-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gluten-free diet; gluten-containing diet; microbiota; metabolomics; healthy volunteers

Outcome Measures

Primary Outcomes (4)

• Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS)

  Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: \<75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and \>300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.

  Baseline(day 0), day 14, day 28, day 42

• Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)

  Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.

  Baseline(day 0), day 14, day 28, day 42

• Change in stool frequency, measured by Bristol Stool Form (BSF)

  Change in Bristol Stool Form, stool frequency per day after both dietary periods

  Day 14, Day 42

• Change in Visceral Sensitivity and Bacterial Fermentation

  Visceral Sensitivity and Bacterial Fermentation measured by the Lactulose-Nutrient Challenge Test.

  Baseline(day 0), day 14, day 28, day 42

Secondary Outcomes (9)

• Change in Central Sensitization Inventory (CSI) score

  Baseline(day 0), day 14, day 28, day 42

• Change in Hospital Anxiety and Depression Scale (HADS) score

  Baseline(day 0), day 14, day 28, day 42

• Change in Highly Sensitive Person Scale (HSPS)

  Baseline(day 0), day 14, day 28, day 42

• Change in Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL)

  Baseline(day 0), day 14, day 28, day 42

• Change in Patient health questionnaire-15 (PHQ-15)

  Baseline(day 0), day 14, day 28, day 42

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Gluten-free diet with gluten powder; Other: Gluten-free diet with placebo powder

Group B

EXPERIMENTAL

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

Other: Gluten-free diet with gluten powder; Other: Gluten-free diet with placebo powder

Interventions

Gluten-free diet with gluten powder 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).

Group A; Group B

Gluten-free diet with placebo powder 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 A; Group B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with IBS according to Rome IV criteria

You may not qualify if:

• 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
• strict avoidance of foods

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Magnus Simrén

Gothenburg, Västra Götland, 40530, Sweden

Location

Related Publications (1)

• Algera JP, Magnusson MK, Ohman L, Storsrud S, Simren M, Tornblom H. Randomised controlled trial: effects of gluten-free diet on symptoms and the gut microenvironment in irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Nov;56(9):1318-1327. doi: 10.1111/apt.17239. Epub 2022 Sep 29.

  PMID: 36173041 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Magnus Simrén, MD, PhD

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Senior Consultant

Model Details: Randomized, Double-blind, Placebo-controlled, Cross-over Trial

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 11, 2019
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

SE (1)