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

NCT02893709 | Completed DMC

• 1 other identifier: FAMES
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (4)

• Change in species diversity after omeprazole treatment, as measured by diversity indices

  1 week, 2 weeks

• Emergence of signature taxa after omeprazole treatment, as measured by indicator value

  1 week, 2 weeks

• Differences in species diversity between gender, as measured by diversity indices

  Baseline

• Differences signature taxa among ethnic groups, as measured by indicator value

  Baseline

Study Arms (1)

Omeprazole

EXPERIMENTAL

A course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days

Drug: Omeprazole

Interventions

Omeprazole DRUG

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

Also known as: Omezole20

Omeprazole

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed written informed consent,
• Aged between 21-35 years of age,
• Chinese, Malay or Indian ancestry through three generations,
• Clinical laboratory assessment results within normal limits, unless the deviation is considered not clinically significant by the investigator,
• Subject is healthy with no clinically significant disease or condition as determined through their medical history, physical examination, and results from clinical laboratory tests that are performed within 2 weeks before the baseline visit at Day 1,
• Ability to communicate with the investigator and to understand and comply with all requirements of study participation.
• Female subjects must be in the first half of their menstrual cycle (i.e. 1 to 14 days after the end of the previous menstruation) at Research Study entry.

You may not qualify if:

• Any acute illness within 2 weeks before Day 1, unless otherwise approved by the PI,
• Presence of chronic illnesses e.g. diabetes, renal disease, gastrointestinal disease, etc., which, in the opinion of the investigator, could compromise the data of the study,
• Subjects who declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),
• Treatment within the previous 3 months with antibiotics,
• Treatment with any prescription or over-the-counter (OTC) medications, or herbal supplements within 4 weeks of Day 1 unless approved by the PI,
• Consumption of probiotics or lactobacillus-containing products e.g. Yakult, Vitagen or Yogurt within 4 weeks of Day 1 unless approved by the PI,
• Abnormal biochemistry indicators,
• Poor peripheral venous access,
• Involvement in the planning or conduct of this study,
• Irregular bowel habits or complains of constipation problem.

Sponsors & Collaborators

• Changi General Hospital: lead
• National University of Singapore: collaborator
• Universiti Teknologi Mara: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

Related Publications (4)

• Freedberg DE, Toussaint NC, Chen SP, Ratner AJ, Whittier S, Wang TC, Wang HH, Abrams JA. Proton Pump Inhibitors Alter Specific Taxa in the Human Gastrointestinal Microbiome: A Crossover Trial. Gastroenterology. 2015 Oct;149(4):883-5.e9. doi: 10.1053/j.gastro.2015.06.043. Epub 2015 Jul 9.

  PMID: 26164495 BACKGROUND

• Jackson MA, Goodrich JK, Maxan ME, Freedberg DE, Abrams JA, Poole AC, Sutter JL, Welter D, Ley RE, Bell JT, Spector TD, Steves CJ. Proton pump inhibitors alter the composition of the gut microbiota. Gut. 2016 May;65(5):749-56. doi: 10.1136/gutjnl-2015-310861. Epub 2015 Dec 30.

  PMID: 26719299 BACKGROUND

• Clooney AG, Bernstein CN, Leslie WD, Vagianos K, Sargent M, Laserna-Mendieta EJ, Claesson MJ, Targownik LE. A comparison of the gut microbiome between long-term users and non-users of proton pump inhibitors. Aliment Pharmacol Ther. 2016 May;43(9):974-84. doi: 10.1111/apt.13568. Epub 2016 Feb 29.

  PMID: 26923470 BACKGROUND

• Imhann F, Bonder MJ, Vich Vila A, Fu J, Mujagic Z, Vork L, Tigchelaar EF, Jankipersadsing SA, Cenit MC, Harmsen HJ, Dijkstra G, Franke L, Xavier RJ, Jonkers D, Wijmenga C, Weersma RK, Zhernakova A. Proton pump inhibitors affect the gut microbiome. Gut. 2016 May;65(5):740-8. doi: 10.1136/gutjnl-2015-310376. Epub 2015 Dec 9.

  PMID: 26657899 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tiing Leong Ang, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Gastroenterologist

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 8, 2016
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)