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

(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).