Comparison Between Low FODMAP and SSRD in IBS

NCT05192603 | Enrolling By Invitation

• 1 other identifier: IBS-2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.

Conditions

IBS - Irritable Bowel Syndrome

Keywords

IBS; low FODMAP; SSRD

Outcome Measures

Primary Outcomes (4)

• Efficiency on bowel and extra-intestinal symptoms

  To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

  4 weeks dietary intervention

• Efficiency on bowel and extra-intestinal symptoms

  To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

  A follow-up 5 months after the end of the intervention

• Efficiency on bowel symptoms

  To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

  4 weeks dietary intervention

• Efficiency on bowel symptoms

  To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

  A follow-up 5 months after the end of the intervention

Secondary Outcomes (23)

• Effects on plasminogen activator inhibitor-1 (PAI-1)

  4 weeks dietary intervention, with a follow-up after another 5 months

• Effects on C-peptide

  4 weeks dietary intervention, with a follow-up after another 5 months

• Effects on insulin

  4 weeks dietary intervention, with a follow-up after another 5 months

• Effects on leptin

  4 weeks dietary intervention, with a follow-up after another 5 months

• Effects on gastric inhibitory peptide (GIP)

  4 weeks dietary intervention, with a follow-up after another 5 months

Study Arms (2)

Dietary intervention with Low FODMAP

EXPERIMENTAL

The participants are given oral and written instructions on which diet that contains low contents of FODMAP.

Dietary Supplement: low FODMAP or SSRD

Dietary intervention with SSRD

EXPERIMENTAL

The participants are given oral and written instructions on which diet that contains SSRD.

Dietary Supplement: low FODMAP or SSRD

Interventions

low FODMAP or SSRD DIETARY_SUPPLEMENT

The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant

Dietary intervention with Low FODMAP; Dietary intervention with SSRD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Verified IBS according to Rom IV criteria.

You may not qualify if:

• Serious mental disease
• Serious somatic disease
• Abuse
• Inability to understand the Swedish language
• Already on a diet

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Deartment of INternal Medicine

Malmo, 20502, Sweden

Location

Related Publications (3)

• Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x.

  PMID: 39227769 DERIVED

• Roth B, Ohlsson B. Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome. F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024.

  PMID: 38939366 DERIVED

• Roth B, Ohlsson B. A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency. Nutrition. 2024 Jan;117:112254. doi: 10.1016/j.nut.2023.112254. Epub 2023 Oct 8.

  PMID: 37924624 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Bodil Ohlsson, Professor

  Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

• Bodil Roth, PhD

  Department of Internal Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, open study for dietary intervention

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 14, 2022
• Study Start: March 1, 2022
• Primary Completion: February 13, 2024
• Study Completion (Estimated): March 31, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)