Low FODMAP diet for treating moderate to severe IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of a low FODMAP diet in patients with moderate to severe Irritable Bowel Syndrome (IBS) who do not have lactose malabsorption. The study aims to determine if dietary changes can alleviate symptoms associated with IBS, such as abdominal pain and bloating. Participants will be assessed based on the Rome IV criteria for IBS and will follow a specific dietary regimen to evaluate improvements in their condition. The trial is designed to provide insights into the role of diet in managing IBS symptoms.

Why it matters

Who can join: the full rules

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 (patients can be included when this disorder had been excluded);
* Known lactose intolerance;
* Known inflammatory bowel disorder;
* Known major intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of appendectomy);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 8 weeks;
* Intake of antibiotics, pre- or probiotics during the past 8 weeks;
* Dietary supplements unless taken at a stable dose for more than 8 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a stable dose for more than 12 weeks is allowed);
* Treatment with spasmolytic agents, opioids, loperamide, gelatin tannate or mucoprotectants during the past 8 weeks;
* LFD or low FODMAP diet in the past.

Where it's running

• UZ Brussel
  Jette, Brussels Capital, Belgium Recruiting

Study contacts

• Principal investigator: Sébastien Kindt, MD — Universitair Ziekenhuis Brussel
• Study coordinator: Sébastien Kindt, MD
• Email: sebastien.kindt@uzbrussel.be
• Phone: +32 2 476

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.