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RECRUITING
NCT06420843
NA

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

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2021-12-22

Completion Date

2024-12-31

Last Updated

2024-05-20

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

FOODMAP

Dietary restriction of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) have been recently investigated in the management of functional gut symptoms in IBS.

Locations (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, Italy