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Enrolling by invitation NCT05192603

Comparison Between Low FODMAP and SSRD in IBS

No phase Interventional IBS - Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low FODMAP or SSRD.
Who it may be relevant to
Registry conditions: IBS - Irritable Bowel Syndrome. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)

Overview

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.

Detailed description

The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.

Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.

The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.

The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.

Statistics

The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.

Interventions

  • Dietary supplement low FODMAP or SSRD
    The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant

Primary outcome measures

  • Efficiency on bowel and extra-intestinal symptoms [Time frame: 4 weeks dietary intervention]
  • Efficiency on bowel and extra-intestinal symptoms [Time frame: A follow-up 5 months after the end of the intervention]
  • Efficiency on bowel symptoms [Time frame: 4 weeks dietary intervention]
  • Efficiency on bowel symptoms [Time frame: A follow-up 5 months after the end of the intervention]
Secondary outcome measures (12)
  • Effects on plasminogen activator inhibitor-1 (PAI-1) [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on C-peptide [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on insulin [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on leptin [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on gastric inhibitory peptide (GIP) [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on visfatin [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on ghrelin [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on gut microbiota by whole genome sequencing of feces [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on microRNA [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on DNA methylation [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects depending on genetics [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]
  • Effects on vitamin A [Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months]

Eligibility criteria

Inclusion criteria

  • Verified IBS according to Rom IV criteria.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Deartment of INternal Medicine — Malmö

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT05192603 · IBS-2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗