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Gut feeling: can a probiotic lift mood in stomach disorder?

NCT ID NCT07182890

Symptom relief Sponsor: Xijing Hospital of Digestive Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Clostridium butyricum can help reduce anxiety and depression in people with functional dyspepsia (a common stomach disorder). 180 adults will receive either the probiotic or a placebo for 4 weeks, alongside standard stomach medication. The main goal is to see if mood scores improve.

What this could mean

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

Active substance
Clostridium butyricum (a probiotic)
What this could lead to
If it works, this could offer a simple, gut-friendly way to improve mood and stomach symptoms together.
What could go wrong
This is a small, early-phase trial. The effect may be small or no better than placebo, and results may not apply to everyone with dyspepsia.

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 180 people

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

Started

Sep 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 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: * Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria. * Aged 18 to 80 years, regardless of gender. * Hospital Anxiety and Depression Scale (HADS) score between 8 and 14. Exclusion Criteria: * Use of probiotics or antibiotics within one month prior to the trial. * Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial. * Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial. * Participation in any other clinical trial within one month prior to the study. * Positive test for Helicobacter pylori (Hp) infection. * Long-term use of traditional Chinese herbal medicine. * Pregnancy or lactation. * History of drug abuse. * Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc. * History of major surgery or diagnosis of diabetes mellitus. * Refusal to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder dyspepsia functional gastric disease

As listed by the trial registrant

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

Anxiety Depression Functional dyspepsia Probiotics

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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Air Force Medical University

    RECRUITING

    Xi’an, Shanxi, China

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