Viewing Study NCT02893709



Ignite Creation Date: 2024-05-06 @ 9:03 AM
Last Modification Date: 2024-10-26 @ 12:09 PM
Study NCT ID: NCT02893709
Status: COMPLETED
Last Update Posted: 2016-09-08
First Post: 2016-08-24

Brief Title: Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community FAMES
Sponsor: Changi General Hospital
Organization: Changi General Hospital

Study Overview

Official Title: Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community FAMES
Status: COMPLETED
Status Verified Date: 2016-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FAMES
Brief 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 n12 Malay n12 and Indian n10 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None