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Could a probiotic boost antidepressants? new trial tests Gut-Brain mood link

NCT ID NCT07691749

Disease control Sponsor: Dr Sadia yasir 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tests whether adding a specific blend of two probiotics (Lactobacillus helveticus and Bifidobacterium longum) to standard antidepressant medication helps reduce depression symptoms more than antidepressants alone. Adults aged 18 to 60 with major depressive disorder who are already on a stable dose of an SSRI antidepressant will take either the probiotic or a placebo capsule daily for six weeks. Researchers will measure changes in depression scores and monitor safety.

What this could mean

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

Active substance
Lactobacillus helveticus and Bifidobacterium longum (psychobiotic probiotic blend)
What this could lead to
If it works, this could point toward a simple, safe add-on treatment that boosts the effectiveness of standard antidepressants for major depression.
What could go wrong
This is a small, early-stage trial. The probiotic may not outperform placebo, and results may not apply to all people with depression.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 86 people

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

Started

Jan 2026

Expected to finish

Jan 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 60 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: 1. Patients diagnosed with major depressive disorder (According to Diagnostic \& Statistical Manual-5 criteria (as per operational definition) 2. Age 18 to 60 years 3. Both genders 4. Patients who are able to speak and understand Urdu/ English language. 5. Patients who are on stable doses of oral selective serotonin reuptake inhibitors for at least two weeks prior to enrollment in the study 6. Patients with cut off score of \> 24 as assessed by 17 item clinician administered Hamilton depression rating scale. Exclusion Criteria: * Severe psychiatric comorbidities (schizophrenia, bipolar disorder, co morbid substance use) * Individuals with weakened immune systems: This includes patients undergoing chemotherapy, transplant recipients, and people with conditions like HIV/AIDS. * Individuals on chronic medication: People on chronic pharmacological therapy, especially with anti-inflammatory drugs or who have recently used antibiotics in last 2 weeks. * Pregnant or lactating women * Current use of probiotics or prebiotics

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depression

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

  • Allama Iqbal Medical College, Jinnah Hospital Lahore

    RECRUITING

    Lahore, Punjab Province, 54550, Pakistan

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