Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

NCT ID: NCT05951972

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2025-08-01

Brief Summary

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

Detailed 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.

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Nutritional intervention

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).

Group Type: EXPERIMENTAL

nutritional

Intervention Type: OTHER

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

Interventions

nutritional

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eran Elinav

OTHER

Sponsor Role: lead

Responsible Party

Eran Elinav

Professor Eran Elinav

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Weizmann Institute of Science

Rehovot, , Israel

Countries

Israel

Other Identifiers

2129-2

Identifier Type: -

Identifier Source: org_study_id