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.
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