Gastroesophageal Reflux DiseaseFAMESNCT02893709
Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)
A study testing Omeprazole in people with Gastroesophageal Reflux Disease, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Abnormal biochemistry indicators,
- Poor peripheral venous access,
- Involvement in the planning or conduct of this study,
- Irregular bowel habits or complains of constipation problem.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Omeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Omezole20
Oral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Experimental | A course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in species diversity after omeprazole treatment, as measured by diversity indices
Measured: 1 week, 2 weeks
Emergence of signature taxa after omeprazole treatment, as measured by indicator value
Measured: 1 week, 2 weeks
Differences in species diversity between gender, as measured by diversity indices
Measured: Baseline
Differences signature taxa among ethnic groups, as measured by indicator value
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, Universiti Teknologi Mara
- Responsible party
- Principal investigator, Ang Tiing Leong, Changi General Hospital
- Investigators
- Tiing Leong Ang, MD, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893709
- Sponsor's protocol ID
- FAMES
- Acronym
- FAMES
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 26164495Jackson 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 26719299Clooney 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 26923470Imhann 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)
- ClinicalTrials.gov ID
- NCT02893709
- Acronym / sponsor ID
- FAMES / FAMES
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- National University of Singapore, Universiti Teknologi Mara
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Experimental | Drug: OmeprazoleA course of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmeprazoleAlso: Omezole20Oral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days | Drug | Omeprazole |
Primary outcome
Change in species diversity after omeprazole treatment, as measured by diversity indices
Time frame: 1 week, 2 weeks
Emergence of signature taxa after omeprazole treatment, as measured by indicator value
Time frame: 1 week, 2 weeks
Differences in species diversity between gender, as measured by diversity indices
Time frame: Baseline
Differences signature taxa among ethnic groups, as measured by indicator value
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 26164495Freedberg 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.
- Background: PubMed 26719299Jackson 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.
- Background: PubMed 26923470Clooney 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.
- Background: PubMed 26657899Imhann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiing Leong Ang, MD principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole in people with Gastroesophageal Reflux Disease, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in species diversity after omeprazole treatment, as measured by diversity indices (time frame: 1 week, 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893709, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.