NCT04373304 (FIBS) is a NA clinical trial of low FODMAP diet in Irritable Bowel Syndrome, sponsored by Universitaire Ziekenhuizen KU Leuven.

Who is sponsoring NCT04373304?

NCT04373304 is sponsored by Universitaire Ziekenhuizen KU Leuven.

What drugs are being tested in NCT04373304?

Interventions in NCT04373304: low FODMAP diet.

What condition does NCT04373304 study?

NCT04373304 studies Irritable Bowel Syndrome, FODMAP.

Is NCT04373304 still recruiting?

NCT04373304 is currently status unknown. Last updated 8 May 2020.

Last reviewed 2020-05-08 · How we verify

NCT04373304: FIBS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Status unknown NA Last updated 8 May 2020

What this trial tests

NA trial testing low FODMAP diet in Irritable Bowel Syndrome in 45 participants. Status unknown.

Timeline

25 November 2019

Primary endpoint
1 July 2021

1 July 2021

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	25 November 2019
Primary completion	1 July 2021
Estimated completion	1 July 2021
Sites	1 location across Belgium

Drugs / interventions tested

low FODMAP diet

Conditions studied

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

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

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

Sponsor's own description

Tertiary care IBS patients will be recruited for a prospective low FODMAP intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different FODMAP groups administered as powder, to be added to the strict FODMAP exclusion phase. During the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. Predictors of treatment response (a 50-point drop on the IBS-severity scoring system (IBS-SSS) during the strict FODMAP exclusion phase of 6 weeks) will be studied with linear mixed models.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and Findings of a Blinded Randomized Reintroduction Phase for the Low FODMAP Diet in Irritable Bowel Syndrome.
Van den Houte K, Colomier E, Routhiaux K, Mariën Z, et al · · 2024 · cited 23× · PMID 38401741 · DOI 10.1053/j.gastro.2024.02.008

Verify or expand the search:

Other trials of low FODMAP diet

Trials testing the same drug.

NCT06541938 — AIRE-2 Device for Study of Breath Analysis in IBD · NA · recruiting
NCT04627727 — Effect of a Low FODMAP Diet on SIBO Breath Test Positivity · EARLY_PHASE1 · terminated
NCT06388330 — The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms · NA · completed

Other recruiting trials for Irritable Bowel Syndrome

Currently open trials in the same condition.

NCT07235228 — Effects of Vivatlac Synbiotic on Gut Micribiota of IBS Patients · NA · recruiting
NCT07421011 — Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 · Phase 1 · recruiting
NCT07360938 — Drug Interaction Potential of Pro-Inflammatory Conditions · recruiting
NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

NCT06831955 — LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer · Phase 2 · recruiting
NCT07356505 — Efficacy and Safety of Micra AV2 Transcatheter Pacing System · NA · recruiting
NCT07286968 — Gastro-Intestinal Digestion and Physiology After Bariatric Surgery · recruiting
NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
NCT07270536 — Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04373304 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
Last refreshed: 8 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04373304.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing