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

Launched by ISTITUTO CLINICO HUMANITAS · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different diets can help manage Irritable Bowel Syndrome (IBS) using advanced technology to personalize nutrition. Participants will be divided into two groups to try different combinations of a low FODMAP diet, which is known to help with IBS symptoms. One group will start with a low FODMAP diet supplemented with fermented milk, then switch to fermented beans, while the other group will do the opposite. Researchers will analyze how these diets affect the gut bacteria and overall health of the participants over a two-week period.

To participate in this study, you need to be between 18 and 70 years old and have a confirmed diagnosis of IBS. It's important that you're willing to follow the diet throughout the study. Unfortunately, individuals with certain conditions like diabetes, those who are pregnant or breastfeeding, or people with recent serious health issues may not be eligible. If you join, you can expect to have your gut health and weight monitored during the study, and the entire process will last for about a year. This research aims to help create better dietary options for people living with IBS.

Gender

ALL

Eligibility 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)