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

NCT06420843 | Recruiting

• 1 other identifier: 3007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Microbiome

  The primary endpoint will be the change in the phenotype of microbiome and metabolome in the two-study group at the end of the assumption of fermented food. Stool samples will be thoroughly analyzed for microbiome (amplified for 16S rDNA sequencing and/or shotgun) and metabolome composition (untargeted). IBS-related symptoms will also be evaluated at the end of one week of low FODMAP diet consumption.

  1 week

Secondary Outcomes (2)

• Microbiome after baseline

  2 weeks

• GSRS score

  1 week

Study Arms (2)

low FODMAP milk

EXPERIMENTAL

Patients will receive one week of low FODMAP diet supplemented with fermented milk followed by one week of low FODMAP diet supplemented with fermented beans.

Dietary Supplement: FOODMAP

low FODMAP beans

ACTIVE COMPARATOR

The second group will receive low FODMAP diet supplemented for one week with fermented beans followed by a second week of low FODMAP diet supplemented with fermented milk.

Dietary Supplement: FOODMAP

Interventions

FOODMAP DIETARY_SUPPLEMENT

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

low FODMAP beans; low FODMAP milk

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Vincenzo Craviotto, MD

CONTACT

0282243113; vincenzo.craviotto@humanitas.it

Alessandro D'Aprano

CONTACT

0282243678; alessandro.daprano@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: December 22, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

IT (1)