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CompletedNCT02893709FAMESUpdated Sep 8, 2016

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

An interventional study of Omeprazole in Gastroesophageal Reflux Disease, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-08.

Sponsored by Changi General Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
21 Years to 37 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastroesophageal Reflux Disease
03

In context

Gastroesophageal Reflux

1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.

This study's enrollment of 36 is below the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Changi General Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Browse Changi General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 37 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed written informed consent,
  2. Aged between 21-35 years of age,
  3. Chinese, Malay or Indian ancestry through three generations,
  4. Clinical laboratory assessment results within normal limits, unless the deviation is considered not clinically significant by the investigator,
  5. 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,
  6. Ability to communicate with the investigator and to understand and comply with all requirements of study participation.
  7. 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

Exclusion Criteria:

  1. Any acute illness within 2 weeks before Day 1, unless otherwise approved by the PI,
  2. 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,
  3. Subjects who declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),
  4. Treatment within the previous 3 months with antibiotics,
  5. Treatment with any prescription or over-the-counter (OTC) medications, or herbal supplements within 4 weeks of Day 1 unless approved by the PI,
  6. Consumption of probiotics or lactobacillus-containing products e.g. Yakult, Vitagen or Yogurt within 4 weeks of Day 1 unless approved by the PI,
  7. Abnormal biochemistry indicators,
  8. Poor peripheral venous access,
  9. Involvement in the planning or conduct of this study,
  10. Irregular bowel habits or complains of constipation problem.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Omeprazole

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

    Drug: Omeprazole

Interventions

  • DrugOmeprazole

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

    Also known as: Omezole20

06

What researchers measure

Primary outcomes

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

    Time frame: 1 week, 2 weeks

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

    Time frame: 1 week, 2 weeks

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

    Time frame: Baseline

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

    Time frame: Baseline

07

Study locations

1 site
  • Changi General Hospital
    Singapore, Singapore 529889, Singapore
08

References and documents

Publications

  • 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. PubMed 26164495 ↗
  • 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. PubMed 26719299 ↗
  • 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. PubMed 26923470 ↗
  • 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. PubMed 26657899 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2016
First posted
Sep 8, 2016
Start
Jun 2015
Primary completionActual
Jul 2016
CompletionActual
Jul 2016
Last update
Sep 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02893709
Lead sponsor
Changi General Hospital
Collaborators
National University of Singapore, Universiti Teknologi Mara
Responsible party
Ang Tiing Leong (Senior Consultant Gastroenterologist, Changi General Hospital) — Principal investigator
First posted
Sep 8, 2016
Start date
Jun 2015
Primary completion
Jul 2016
Completion
Jul 2016
Last update
Sep 8, 2016

Study contacts

Tiing Leong Ang, MD
principal investigator · Changi General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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