Clinical Trials Directory

Trials / Completed

CompletedNCT02893709

Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Changi General Hospital · Academic / Other
Sex
All
Age
21 Years – 37 Years
Healthy volunteers
Accepted

Summary

The objectives of this study are to examine the effects of ethnicity, gender, and proton pump inhibitor (PPI, omeprazole), on the human gut microbiome. The investigators hypothesize that PPI therapy might perturb microbial communities and alter the gut microbiome. Young, healthy subjects of Chinese, Malay and Indian ancestry, were enrolled. They were required to provide a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and Day 14 (one week after stopping omeprazole). The DNA samples were subjected to 16S ribosomal ribonucleic acid (rRNA) sequencing.

Detailed description

Background and Aim: The objectives of this study are to examine the effects of ethnicity, gender, and proton pump inhibitor (PPI, omeprazole), on the human gut microbiome. PPIs are commonly used for the treatment of acid-related disorders. The investigators hypothesize that PPI therapy might perturb microbial communities and alter the gut microbiome. Methods: Healthy subjects of Chinese (n=12), Malay (n=12) and Indian (n=10) ancestry, aged 21-37 years old, were enrolled. They were required to provide a baseline stool sample (Day 1) and were then given a course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days. Stool samples were collected again on Day 7 and Day 14 (one week after stopping omeprazole). Microbial DNA was extracted from the stool samples. This was followed by PCR, library construction, 16S rRNA sequencing using Illumina MiSEQ, and statistical and bioinformatics analyses.

Conditions

Interventions

TypeNameDescription
DRUGOmeprazoleOral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days

Timeline

Start date
2015-06-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2016-09-08
Last updated
2016-09-08

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT02893709. Inclusion in this directory is not an endorsement.