Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

Eran Elinav

Status: Completed

Conditions: Nutrition, Healthy

Treatments: Other: nutritional

Study type: Interventional

Funder types: Other

Identifiers

NCT05951972

2129-2

Details and patient eligibility

About

This study will assess global small molecule profiles identified in the human gastrointestinal tract of healthy human volunteers.

Full description

The gut is home to an extensive interaction between the host and its microbiota, in different regions exposed to endogenous and exogenous signals, such as nutrition, medications, immune alterations, and geographical location-related factors. this study aims to characterize the small molecule profiles of a cohort of healthy individuals, including their polar, semi-polar, non-polar, and protein landscape. The investigators will develop a pipeline enabling to integrate these small molecule profiles with a variety of inter-individual readouts, as assessed in stools of healthy volunteers. Data will be used to characterize molecular patterns potentially associated with a variety of dietary, immune, and health-related human features, with an aim to characterize small molecules for future causative investigation.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Normal BMI
• Age 18-70

Exclusion criteria

• Known food allergies to the tested food items
• Chronic constipation (less than one bowel movement every two days)
• Chronic treatment with any drug upon enrolment.
• The use of systemic antibiotics, probiotics, or proton pump inhibitors 3 months prior to enrollment.
• Diagnosis of type 1 or type 2 diabetes.
• Any chronic disease at the discretion of the study team- such as active or recent cancer, inflammatory bowel disease, systemic autoimmunity
• Any psychiatric disorders
• Alcohol or substance abuse
• Gut-related surgery, including bariatric surgery, but not including previous appendectomy.
• Pregnancy, breastfeeding, or fertility treatments 6 months prior to enrollment for female participants

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Nutritional intervention

Experimental group

Description:

The trial will consist of two short periods in which increased intake of a pair of food items will be implemented. The first pair of food items is apples and bananas (pair A), and the second pair of food items is peanuts and cucumbers (pair B).

Treatment:

Other: nutritional