Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.

Recruiting Phase 3 Interventional Study
Irritable Bowel Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
60 (estimated)
Sponsor
Universitair Ziekenhuis Brussel · Other
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About This Trial
Irritable bowel syndrome (IBS) is a frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or con-sistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. The underlying pathophysiology remains obscure, although …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * \- Patients aged 18 - 75 years; * Fulfilling the ROME IV criteria for IBS; * Moderate symptom severity as defined by a IBS-SSS \> 175; * Consumption of lactose containing products. Exclusion Criteria: * \- Clinical suspicion of an organic disorder different from LI or IBS (p…
Contacts

Sébastien Kindt, MD

+32 2 476

sebastien.kindt@uzbrussel.be

CONTACT