Effect of Proton Pump Inhibitors on Gut Microbiota Composition and Metabolites in Healthy Subjects Using CapScan

Not Applicable

Not yet recruiting

• Conditions: Healthy Subjects

• Registration Number: NCT07054593
• Lead Sponsor: Envivo Bio Inc

Brief Summary

This study is designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.

Detailed Description

Prospective, open-label, single-arm, non-randomized, single-center study designed to evaluate the effect of proton pump inhibitors on the regional composition of the gut microbiota and metabolic profiles of health volunteers using the CapScan collection capsule.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-12-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Identification of the gut microbial taxa using DNA sequencing of the samples obtained from the CapScan devices	2 months	A primary endpoint is to identify and quantitate the relative abundance of the gut microbial taxa using at least 3 million metagenomic DNA sequencing reads in at least 75% of the samples obtained from the CapScan devices.
Identification of the gut metabolites using liquid chromatography - mass spectrometry of the samples obtained from the CapScan devices	2 months	A primary endpoint is to identify at least 1,500 annotated gut metabolites from the intestinal tract in at least 75% of the samples obtained from the CapScan devices.

Secondary Outcome Measures

Name	Time	Method
Detect changes in composition of gut microbial taxa using DNA sequencing in subjects before and after omeprazole treatment	2 months	Evaluate the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of the study population from before and after omeprazole treatment.
Detect changes in composition of gut metabolites using liquid chromatography - mass spectrometry in subjects before and after omeprazole treatment	2 months	Evaluate the diversity, centroids and distributions of gut metabolites in CapScan samples of the study population from before and after omeprazole treatment.

Trial Locations

Locations (1)

Silicon Valley Gastroenterology; 🇺🇸 Mountain View, California, United States