Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

N/ACompletedNCT05951972

Eran Elinav6 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Nutrition, Healthy

Interventions

nutritionalOTHER

participants will receive 2 pairs of food items to consume - pair A - Bananas and Apples, pair B - cucumbers and peanuts.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Weizmann Institute of Science

Rehovot, Israel

Outcomes

Primary Outcomes

Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation

Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples collected during a nutritional intervention. The analysis includes - a shot-gun metagenomics, metabolomics and proteomic anlaysis. The analysis includes - proteomics, metabolomics and a shot-gun metagenomics.

Time frame: 1 month

Data from ClinicalTrials.gov

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