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NCT06420843

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

Istituto Clinico Humanitas·ClinicalTrials.gov·dietary supplementRecruiting
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Study focus
Disease/Condition
IBS - Irritable Bowel Syndrome
Drug/Device/Intervention
FOODMAP
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Istituto Clinico Humanitas
Location
Rozzano, Italy
Timeline & enrollment
Phase
N/A
Start date
Dec 22, 2021
End date
Dec 31, 2024
Enrollment
48 participants
Primary outcome

Microbiome

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.

ICD-10 classifications
Irritable bowel syndrome with predominant constipation [IBS-C]Irritable bowel syndromeIrritable bowel syndrome with predominant diarrhoea [IBS-D]Irritable bowel syndrome with mixed bowel habits [IBS-M]Other and unspecified irritable bowel syndrome
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06420843
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06420843 through Pure Global AI's free database. This phase not specified trial is sponsored by Istituto Clinico Humanitas and is currently Recruiting. The study focuses on IBS - Irritable Bowel Syndrome. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.