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Does a common heartburn drug reshape the Gut's bacterial neighborhood?

NCT ID NCT07850960

Knowledge-focused Sponsor: Federal State Budgetary Scientific Institution Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 01, 2026 · Last updated Oct 02, 2026 · Updated 1 time

Summary

Researchers are testing whether a 14-day course of omeprazole, a common acid reflux drug, changes the mix of bacteria in the gut and mouth. The trial enrolls 26 adults aged 50 to 65 who have obesity and mild to moderate gastroesophageal reflux symptoms. Half receive omeprazole plus standard lifestyle advice, and half receive lifestyle advice alone. Stool, saliva, and blood samples collected before and after treatment will show whether the drug shifts bacterial diversity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omeprazole, a common proton pump inhibitor for acid reflux
What this could lead to
If omeprazole shifts the gut bacteria of people with obesity and reflux, doctors could learn which patients might benefit from monitoring or probiotic support during short courses.
What could go wrong
The trial is small, with 26 participants, and lasts only 14 days, so any bacterial changes may be temporary or not apply to other groups. It measures bacterial composition, not whether those changes affect health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 50 to 65 years, inclusive. * Obesity, defined as body mass index (BMI) ≥30 kg/m². * Symptomatic gastroesophageal reflux disease with mild or moderate typical symptoms, including heartburn and/or regurgitation. * For female participants, postmenopausal status, defined as absence of menstruation for at least 12 months without another apparent cause of amenorrhea. * Written informed consent to participate in the study. Exclusion Criteria: * Severe or exacerbated GERD, or GERD requiring acid-suppressive therapy or additional diagnostic evaluation. * Use of proton pump inhibitors or histamine H2-receptor antagonists within 8 weeks prior to enrollment. * Use of systemic antibiotics within 3 months prior to enrollment. * Use of probiotic or synbiotic supplements within 8 weeks prior to enrollment. * Inflammatory bowel disease, celiac disease, or other severe chronic gastrointestinal disorders that may substantially affect the gut microbiota. * History of bariatric surgery or other major gastrointestinal surgery. * Acute infectious or inflammatory disease at enrollment. * History of myocardial infarction or stroke. * Type 2 diabetes mellitus. * Chronic heart failure, New York Heart Association functional class III-IV. * Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73 m². * Alcohol dependence or other substance use disorder. * Severe psychiatric disorder or cognitive impairment that may interfere with providing informed consent or adherence to the study protocol. * Known hypersensitivity or contraindications to omeprazole.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroesophageal reflux disease Obesity & overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Federal Research Centre of Nutrition, Biotechnology and Food Safety

    Moscow, 115446, Russia

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