Actively Recruiting
Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
Led by Istituto Clinico Humanitas · Updated on 2024-05-20
48
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microbiota, Metabolome and Nutrition: an 'Artificially Intelligent' Way to Personalized Nutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes and any race
- Age 18 to 70 years
- 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
You will not qualify if you...
- Patient age less than 18 or greater than 70 years
- Diabetes (Type 1 or 2)
- Use of probiotic, antibiotic, lactic ferment, or pump inhibitors within 15 days prior to screening
- Pregnant or planning to become pregnant or lactating
- History of HIV or hepatitis B or C
- Participation in investigational study within past 30 days
- Unstable cardiovascular or pulmonary disease with recent treatment change due to worsening condition
- Any concomitant disease requiring specialized nutrition (e.g., renal failure, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089
Actively Recruiting
Research Team
V
Vincenzo Craviotto, MD
CONTACT
A
Alessandro D'Aprano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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