Using human milk oligosaccharides to improve symptoms of irritable bowel syndrome
A Double-blind, Crossover Intervention Study Using Human Milk Oligosaccharides (HMOs) to Improve Irritable Bowel Syndrome (IBS) Symptoms Through Targeting of the Gut Microbiota
This study is trying to see if a substance found in human milk can help people with irritable bowel syndrome feel better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Reading Academic / other |
| Locations | 1 site (Reading, Berkshire) |
| Trial ID | NCT06281600 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on the impact of human milk oligosaccharides (HMO) on patients with irritable bowel syndrome (IBS). The study employs a randomized, placebo-controlled, double-blinded crossover design, where participants will receive either HMO or a maltodextrin placebo over a 28-day period. Patient-reported outcomes will be collected to assess changes in IBS symptoms, as well as secondary outcomes related to anxiety, depression, sleep quality, and gut microbiota composition. The study aims to recruit 44 participants aged 18 to 60 diagnosed with IBS according to the Rome IV criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a clinical diagnosis of irritable bowel syndrome.
Not a fit: Patients with other gastrointestinal conditions or those who have recently participated in similar dietary interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly alleviate IBS symptoms and improve the quality of life for patients.
How similar studies have performed: While the use of dietary interventions in IBS is explored, this specific approach using HMOs is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed consent form. * Adults (aged from 18 to 60). * Diagnosis of irritable bowel syndrome by a clinician (according to the Rome IV criteria). * Absence of gut conditions other than IBS. Exclusion Criteria: * Intake of an experimental drug within four weeks prior to study. * Former participation in prebiotic, probiotic or laxative trials within the previous four weeks. * Former participation in a dietary intervention within the previous four weeks. * Use of antibiotics within the previous four weeks. * Intake of other specific prebiotics (such as oligosaccharides e.g. inulin), or probiotics (e.g. live yoghurts, other fermented products), drugs active on gastrointestinal motility, or a laxative of any class, for four weeks prior to study. * Women who are lactating, pregnant or planning pregnancy during the study period.
Where this trial is running
Reading, Berkshire
- The University of Reading — Reading, Berkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Patricia Sanz Morales
- Email: p.sanzmorales@pgr.reading.ac.uk
- Phone: +447843865554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.