Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

NCT05951972 | Completed

• 1 other identifier: 2129-2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (1)

Nutritional intervention

EXPERIMENTAL

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).

Other: nutritional

Interventions

nutritional OTHER

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

Nutritional intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal BMI
• Age 18-70

You may not qualify if:

• 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

Sponsors & Collaborators

• Eran Elinav: lead

Study Sites (1)

Weizmann Institute of Science

Rehovot, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Eran Elinav

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: July 19, 2023
• Study Start: April 15, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

IL (1)