Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Vincenzo Craviotto, MD
vincenzo.craviotto@humanitas.it
0282243113
Backup
Alessandro D'Aprano
alessandro.daprano@humanitas.it
0282243678
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 48
Treatments
Experimental: low FODMAP milk
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.
Active_comparator: low FODMAP beans
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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov