Personalized nutrition approach for managing IBS
Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
This study is testing if a special diet with fermented milk and beans can help people with Irritable Bowel Syndrome feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milano) |
| Trial ID | NCT06420843 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a low FODMAP diet supplemented with fermented milk and beans on patients with Irritable Bowel Syndrome (IBS). Participants will be randomized into two groups, each receiving different dietary supplements over two weeks. The study aims to evaluate changes in the microbiome, metabolome, and physical characteristics of the patients. Data collection will occur over a year, with analysis of clinical and laboratory data conducted in parallel.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who have been diagnosed with IBS according to the Rome IV criteria.
Not a fit: Patients with diabetes, pregnant or lactating women, and those with certain comorbidities or recent use of specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to personalized dietary interventions that significantly improve the quality of life for IBS patients.
How similar studies have performed: Previous studies have shown promise in using dietary interventions like the low FODMAP diet for managing IBS symptoms, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sex and any race * Age ≥18 and ≤70. * IBS confirmed by Rome IV diagnostic criteria * Willing to adhere to the proposed diet * Provision of written informed consent * Commitment of availability throughout the study period Exclusion Criteria: * Patient age \<18 and \> 70 * Diabetes (Type 1 or 2) * Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening. * Pregnant or planning to become pregnant or is lactating. * History of HIV or hepatitis B or C * Participation in investigational study within past 30 days * Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition * Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
Where this trial is running
Rozzano, Milano
- Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital — Rozzano, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Craviotto, MD
- Email: vincenzo.craviotto@humanitas.it
- Phone: 0282243113
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.