Testing the effects of a lactose-free diet on IBS symptoms using breath tests

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 predictive value of hydrogen and methane breath testing in patients with moderate to severe Irritable Bowel Syndrome (IBS) who are suspected of having lactose intolerance. The study aims to determine how effective a lactose-free diet is in alleviating IBS symptoms based on breath test results. Participants will undergo breath testing to assess lactose malabsorption and will then follow a lactose-free diet to evaluate symptom improvement. The trial is designed to provide insights into dietary management for IBS patients with lactose intolerance.

Why it matters

Who can join: the full rules

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 disorder had been excluded);
* Known lactose intolerance or malabsorption;
* Known inflammatory bowel disorder;
* Known 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 mucoprotect-ants 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

• Study coordinator: Sébastien Kindt, MD
• Email: Sebastien.kindt@uzbrussel.be
• Phone: +32 2 476

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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.