Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS.

Recruiting Phase 3 Interventional Study
Irritable Bowel Syndrome Lactose Intolerant
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
90 (estimated)
Sponsor
Universitair Ziekenhuis Brussel · Other
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About This Trial
Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fatty acids, carbon dioxide, H2 and methane (Catanzaro 2021).…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 (patients can be included when this dis…
Contacts

Sébastien Kindt, MD

+32 2 476

Sebastien.kindt@uzbrussel.be

CONTACT