NCT03653689

Identification of IBS Metabotypes Based on Physiological Responses to Food

Completed NA Last updated 25 September 2019

What this trial tests

NA trial testing FODMAP in Irritable Bowel Syndrome in 110 participants. Completed in 14 June 2019.

Timeline

10 September 2018

Primary endpoint
14 June 2019

14 June 2019

Quick facts

Lead sponsor	Uppsala University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	diagnostic
Enrollment	110
Start date	10 September 2018
Primary completion	14 June 2019
Estimated completion	14 June 2019
Sites	1 location across Sweden

Drugs / interventions tested

• FODMAP
• Gluten
• Placebo

Conditions studied

• Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →

Sponsor

Uppsala University

Who can join

Adults 18 to 70, any sex, with Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Irritable bowel syndrome (IBS) is a condition characterized by abdominal pain, bloating, constipation, diarrhea and gas and affects up to 15% of the Western population. In many individuals with IBS, symptoms can be triggered by foods, such as FODMAPs (easily fermentable dietary fiber containing Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols). Some individuals with IBS may also benefit from a gluten-free diet. Current subtypes of IBS are based on symptoms (constipation, diarrhea, and mixed), rather than mechanistic differences. Another promising approach for identifying IBS subtypes is based on grouping individuals into similar metabolic phenotypes, i.e. metabotypes, that share similarities in metabolism and metabolic regulation in response to specific foods. Health and wellbeing could potentially be improved by personalized treatment through tailoring diet to subjects with different IBS subtypes.

To investigate this hypothesis, the investigators will conduct an intervention study on subjects with IBS and identify specific food susceptibilities based on metabolic phenotype (metabotype). In total, 120 women and men with moderate to severe IBS will be recruited. Gluten intolerance, other gastrointestinal disease and abdominal surgery will constitute exclusion criteria. The study will be performed in a double-blind, randomized, placebo-controlled cross-over study design. Study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. IBS metabotypes will be identified by integrative multivariate analysis of molecular phenotype data from metabolomics and microbiota measurements combined with data on bowel habits and stomach discomfort. Study participants will also be subjected to a cocktail provocation containing FODMAPs and gluten to develop a rapid diagnostic test based on identified plasma metabolomic biomarkers of IBS metabotypes.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gut liver brain axis in diseases: the implications for therapeutic interventions.
   Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
2. Fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs), but not gluten, elicit modest symptoms of irritable bowel syndrome: a double-blind, placebo-controlled, randomized three-way crossover trial.
   Nordin E, Brunius C, Landberg R, Hellström PM. · · 2022 · cited 30× · PMID 34617561 · DOI 10.1093/ajcn/nqab337
3. Effects of FODMAPs and Gluten on Gut Microbiota and Their Association with the Metabolome in Irritable Bowel Syndrome: A Double-Blind, Randomized, Cross-Over Intervention Study.
   Nordin E, Hellström PM, Dicksved J, Pelve E, et al · · 2023 · cited 13× · PMID 37447371 · DOI 10.3390/nu15133045
4. IBS randomized study: FODMAPs alter bile acids, phenolic- and tryptophan metabolites, while gluten modifies lipids.
   Nordin E, Hellström PM, Vuong E, Ribbenstedt A, et al · · 2023 · cited 6× · PMID 37399002 · DOI 10.1152/ajpregu.00016.2023
5. Exploration of differential responses to FODMAPs and gluten in people with irritable bowel syndrome- a double-blind randomized cross-over challenge study.
   Nordin E, Landberg R, Hellström PM, Brunius C. · · 2024 · cited 2× · PMID 38347192 · DOI 10.1007/s11306-023-02083-x