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OpenTrials
Completed

NCT Number: NCT05951972

Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

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

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weizmann Institute of Science

Rehovot, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutritional

Other

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

Primary outcomes

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

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Eran Elinav

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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