Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
Key facts
- Who runs it
- Istituto Clinico Humanitas
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 48 people enrolled
- Started
- 22 Dec 2021
- Ended
- 31 Dec 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- FOODMAP
- Record updated
- 6 November 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Subjects who have used probiotic, antibiotic, lactic ferment or pump inhibitors within 15 days prior to screening
- Any concomitant disease requiring specialized nutrition (e.g. renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
- Diabetes (Type 1 or 2)
- History of HIV or hepatitis B or C
- Unstable cardiovascular or pulmonary disease, with change in treatment in last 30 days due to worsening disease condition
- Patient age <18 and > 70
- Pregnant or planning to become pregnant or is lactating
- Participation in investigational study within past 30 days
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Screening Visit:
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(Week -2, Visit 0) - Eligible patients will be identified and enrolled in a maximum of 2-week period based on the described criteria using the (IBS-SSS). IBS-SSS is a symptom assessment tool that measures the baseline severity and frequency of these symptoms, as well as the response to treatment. The worksheet for calculating the IBS-SSS is a simple and immediate tool. Mild disease is characterized by scores ≥75 and <175, moderate ≥175 and <300, severe if ≥300. To assess the quality of life, IBS-QOL questionnaire was used, also validated in the Italian version. Medical history, height, weight, concomitant medication and a food diary will be collected. This phase may last up to 2 weeks.
Baseline visit:
(Week 0, Visit 1-2) - Enrolled IBS patients will all receive a low FODMAP diet provided by Fooderapy (https://www.fooderapy.it/shop/)(2) for one week to avoid diet-related microbiome and metabolome variability before sample collection. A sample of the feces will be collected during the baseline visit and at the end of one week of low FODMAP diet. Stool samples will be thoroughly analyzed for microbiome (amplified for 16S rDNA sequencing and/or shotgun) and metabolome composition (untargeted). IBS-related symptoms will also be evaluated at the end of one week of low FODMAP diet consumption (IBS-SSS). Data regarding the weight will also be recorded.
Intervention:
(Weeks 1-2, Visit 3-4) - Starting from the second week after the date of consent, patients with IBS will be randomized 1:1 into two groups. The first group (20 patients) will receive one week of a low FODMAP supplemented with fermented milk followed by one week of a low FODMAP content supplemented with fermented beans. The second group (20 patients) will receive a low FODMAP diet supplemented for one week with fermented beans followed by a second week of a diet with a low FODMAP diet supplemented with fermented milk. The microbiome of the patients will be evaluated after the first and second weeks along with data related to weight. After the second week, the metabolome and physical characteristics. The enrollment period will last for one year. The analysis of clinical data will be completed within one year after patient enrollment.
Analysis of laboratory data will be performed in parallel.
Follow-up visit:
(week 10, visit 5) - Patients will be contacted by telephone two months after the end of the treatment in order to evaluate the IBS-related symptoms and quality of life (IBS-SSS and IBS-QOL).
The 2 groups in the trial
- low FODMAP milkTreatment being tested
Patients will receive one week of low FODMAP diet supplemented with fermented milk followed by one week of low FODMAP diet supplemented with fermented beans.
Treatment: FOODMAP
- low FODMAP beansExisting treatment, for comparison
The second group will receive low FODMAP diet supplemented for one week with fermented beans followed by a second week of low FODMAP diet supplemented with fermented milk.
Treatment: FOODMAP
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 November 2026