Low FODMAP diet for treating moderate to severe IBS

Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.

This study is testing if a low FODMAP diet can help people with moderate to severe IBS feel better by reducing symptoms like abdominal pain and bloating.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Universitair Ziekenhuis Brussel (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jette, Brussels Capital)
• Trial ID: NCT05120752 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who meet the Rome IV criteria for IBS and have moderate symptom severity.

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

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from IBS by providing an effective dietary management strategy.

How similar studies have performed: Previous studies have shown beneficial effects of the low FODMAP diet in some IBS patients, indicating a promising approach.

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 (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 this trial is running

Jette, Brussels Capital

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

Study contacts

• Principal investigator: Sébastien Kindt, MD — Universitair Ziekenhuis Brussel
• Study coordinator: Sébastien Kindt, MD

Conditions: Irritable Bowel Syndrome