Actively Recruiting
Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS
Led by Universitair Ziekenhuis Brussel · Updated on 2025-12-18
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lactose intolerance (LI) happens when the body cannot properly digest lactose, causing symptoms like abdominal pain, cramps, gas, and diarrhea. This condition often overlaps with irritable bowel syndrome (IBS), which causes abdominal pain and changes in bowel habits. This study looks at whether a lactose breath test can predict how well people with moderate to severe IBS respond to a lactose-free diet and aims to see if this diet improves quality of life in these patients. Participants will be grouped based on their lactose breath test results into H2BT-positive or H2BT-negative categories. Both groups will receive guidance from a trained dietitian on following a lactose-free diet. The study focuses on evaluating the diet's effect over a short term and longer term, with careful monitoring of symptoms and quality of life changes. During the study, participants' IBS symptoms and severity will be assessed using standardized scales at several visits, including at week 4. Researchers will track symptom improvement and changes in IBS severity scores. The study includes close monitoring for safety and adherence to the diet, with a total participation age range of 18 to 75 years. The study began in 2021 and will continue until 2028.
CONDITIONS
Brief Title
Predictive Value of Hydrogen/Methane Lactose Breath Testing on the Therapeutic Effect of Lactose-free Diet in Moderate to Severe ROME IV IBS.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfilling the ROME IV criteria for IBS
- Moderate symptom severity as defined by a IBS-SSS > 175
- Consumption of lactose containing products
- Age between 18 and 75 years
You will not qualify if you...
- Clinical suspicion of an organic disorder different from LI or IBS unless excluded
- Known lactose intolerance or malabsorption
- Known inflammatory bowel disorder
- Known intestinal motility disorder
- Alcohol use exceeding 14 units per week or other substance abuse
- Active psychiatric disorder
- Known systemic or autoimmune disorder affecting the GI system
- Prior abdominal surgery except appendectomy
- Any prior cancer diagnosis except basocellular carcinoma
- Current chemotherapy
- History of gastro-enteritis within the past 8 weeks
- Use of antibiotics, pre- or probiotics within the past 8 weeks
- Use of dietary supplements unless stable dose for over 8 weeks
- Treatment with neuromodulators unless stable dose for over 12 weeks
- Use of spasmolytic agents, opioids, loperamide, gelatin tannate, or mucoprotectants in past 8 weeks
- Previous lactose-free or low FODMAP diet use within the past period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo hydrogen/methane lactose breath testing to assess lactose intolerance status.
1 visit (in-person)
Duration - 4 weeks
Participants follow a lactose-free diet guided by a trained dietitian to evaluate therapeutic effects on IBS symptoms.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
S
Sébastien Kindt, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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