🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 3Ages 18 Years - 75 YearsAllUniversitair Ziekenhuis Brussel
NCT04974593 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fatty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. These pathophysiological mechanisms encountered in patients suffering from LI generate symptoms, such as abdominal pain and cramps, flatulence, diarrhea, borborygmi among others. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with these symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • low fat diet
📍

Where

1 site
UZ Brussel
Jette, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy