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

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

This study is testing if a lactose-free diet can help people with moderate to severe IBS feel better by using breath tests to see if they have lactose intolerance.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jette, Brussels Capital)
• Trial ID: NCT04974593 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals who meet the ROME IV criteria for IBS and have moderate symptom severity while consuming lactose-containing products.

Not a fit: Patients with known lactose intolerance or other gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help patients with IBS better manage their symptoms through tailored dietary recommendations.

How similar studies have performed: Other studies have shown promising results in managing IBS symptoms through dietary interventions, suggesting that this approach may be effective.

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 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 this trial is running

Jette, Brussels Capital

• UZ Brussel — Jette, Brussels Capital, Belgium (Recruiting)

Study contacts

• Study coordinator: Sébastien Kindt, MD

Conditions Irritable Bowel Syndrome; Lactose Intolerant