Pure Global

Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition - Trial NCT06420843

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.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06420843
Recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06420843
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

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

Study Focus

FOODMAP

Interventional

dietary supplement

Sponsor & Location

Istituto Clinico Humanitas

Rozzano, Italy

Timeline & Enrollment

N/A

Dec 22, 2021

Dec 31, 2024

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 syndrome
Irritable bowel syndrome with predominant diarrhoea [IBS-D]
Irritable bowel syndrome with mixed bowel habits [IBS-M]
Other and unspecified irritable bowel syndrome

Data Source

ClinicalTrials.gov

NCT06420843

Non-Device Trial