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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Omeprazole

About this trial

This is an interventional basic science trial for Gastroesophageal Reflux Disease

Eligibility Criteria

21 Years - 37 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Changi General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omeprazole

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02893709

First Posted

August 24, 2016

Last Updated

September 3, 2016

Sponsor

Changi General Hospital

Collaborators

National University of Singapore, Universiti Teknologi Mara

1. Study Identification

Unique Protocol Identification Number

NCT02893709

Brief Title

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

Acronym

FAMES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changi General Hospital

Collaborators

National University of Singapore, Universiti Teknologi Mara

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omeprazole

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Omeprazole

Other Intervention Name(s)

Omezole20

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1 week, 2 weeks

Title

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

Time Frame

1 week, 2 weeks

Title

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

Time Frame

Baseline

Title

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiing Leong Ang, MD

Organizational Affiliation

Changi General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changi General Hospital

City

Singapore

ZIP/Postal Code

529889

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26164495

Citation

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.

Results Reference

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PubMed Identifier

26719299

Citation

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.

Results Reference

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PubMed Identifier

26923470

Citation

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.

Results Reference

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PubMed Identifier

26657899

Citation

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.

Results Reference

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

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