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Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951972
Enrollment
6
Registered
2023-07-19
Start date
2023-04-15
Completion date
2025-08-01
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

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.

Interventions

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

Sponsors

Eran Elinav
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of gut microbiota and associated molecules in the healthy human gastrointestinal tract upon nutritional supplementation1 monthIdentification 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026