The Effects of FODMAPs in Patients With Irritable Bowel Syndrome

NCT05182593 | Completed

• 1 other identifier: 394-18
• Study Type: interventional
• Target: 30
• 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 low FODMAP diet. To investigate relation of FODMAPs and IBS, a randomized, double-blind, cross-over trial will be carried out in adult (\>18) patients with IBS according to Rome IV criteria. The aim is to assess low FODMAP diet versus moderate/high FODMAP diet in IBS patients.

Conditions

Irritable Bowel Syndrome

Keywords

FODMAPs; carbohydrates; gastrointestinal symptoms; IBS

Outcome Measures

Primary Outcomes (3)

• Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (7-10 days recall questionnaire)

  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 7, day 21, day 28

• Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (modified, daily 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.

  Daily during day 7 to 14, and day 21 to 28

• 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 7, day 21, day 28

Secondary Outcomes (4)

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

  Baseline (day 0), day 7, day 21, day 28

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

  Baseline (day 0), day 7, day 21, day 28

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

  Baseline (day 0), day 7, day 21, day 28

• Change in Visceral Sensitivity Index (VSI)

  Baseline (day 0), day 7, day 21, day 28

Other Outcomes (3)

• Visceral Sensitivity and Bacterial Fermentation

  Baseline (day 0)

• Change in microbiota content of frozen fecal samples

  Baseline (day 0), day 7, day 21, day 28

• Change in metabolites content

  Baseline (day 0), day 7, day 21, day 28

Study Arms (2)

Diet 1: moderate/high FODMAP diet. Diet 2: low FODMAP diet.

EXPERIMENTAL

The subjects will follow the moderate/high FODMAP diet as the first intervention, and the low FODMAP diet as the second intervention. The subjects will follow both interventions for seven days.

Other: Diet moderate/high in FODMAPs; Other: Diet low in FODMAPs

Diet 1: low FODMAP diet. Diet 2: moderate/high FODMAP diet.

EXPERIMENTAL

The subjects will follow the low FODMAP diet as the first intervention, and the moderate/high FODMAP diet as the second intervention. The subjects will follow both interventions for seven days.

Other: Diet moderate/high in FODMAPs; Other: Diet low in FODMAPs

Interventions

Diet moderate/high in FODMAPs OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a moderately high FODMAP content (23 grams/day)

Diet 1: low FODMAP diet. Diet 2: moderate/high FODMAP diet.; Diet 1: moderate/high FODMAP diet. Diet 2: low FODMAP diet.

Diet low in FODMAPs OTHER

The subjects will obtain meal boxes prepared in the hospital kitchen with a low FODMAP content (\<5 grams/day)

Diet 1: low FODMAP diet. Diet 2: moderate/high FODMAP diet.; Diet 1: moderate/high FODMAP diet. Diet 2: low FODMAP diet.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• 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 disease
• severe hepatic disease
• severe neurological disease
• severe psychiatric disease
• celiac disease
• inflammatory bowel diseases
• 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 Simren

Gothenburg, Non-US/Non-Canadian, 44331, Sweden

Location

Related Publications (1)

• Algera JP, Demir D, Tornblom H, Nybacka S, Simren M, Storsrud S. Low FODMAP diet reduces gastrointestinal symptoms in irritable bowel syndrome and clinical response could be predicted by symptom severity: A randomized crossover trial. Clin Nutr. 2022 Dec;41(12):2792-2800. doi: 10.1016/j.clnu.2022.11.001. Epub 2022 Nov 4.

  PMID: 36384081 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Magnus Simrén, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

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 meal boxes which looked similar.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: February 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: September 1, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)