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Gut-Brain boost: psychobiotic plus diet shows promise for obese women

NCT ID NCT06861049

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a daily psychobiotic supplement (a mix of friendly bacteria) plus a weight-loss diet could improve mental health, quality of life, and body measurements in 28 obese women over 4 weeks. Participants were randomly assigned to receive either the supplement or a placebo, and researchers tracked changes in weight, BMI, mood, and inflammation markers. The goal is to see if targeting the gut-brain connection can help both mental health and obesity.

What this could mean

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

Active substance
Psychobiotic supplement (Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium longum R0175)
What this could lead to
If it works, this could point toward a simple supplement to boost mental health and weight loss in obese women.
What could go wrong
This is a very small, short-term study (28 women, 4 weeks). Results may not apply to everyone, and the effect may be small or not last.

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

40 people

The number who actually took part.

Started

Feb 2025

Finished

Jul 2025

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 65 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy adults aged ≥ 18-65 years * BMI ≥30 kg/m2 * Willingness to volunteer * Able to give written consent Exclusion Criteria: * Co-administration of probiotics. However, subjects will be eligible to participate after a four (4) week washout period. * Pregnant or planning to become pregnant within the next two (2) months. * Positive pregnancy test in women of childbearing potential. * Use of antibiotic medication (e.g. neomycin, rifaximin) within the last 1 month. If this is the case, the participant will be eligible to participate four (4) weeks after completion of antibiotic treatment (washout period). * Individuals with physician-diagnosed psychiatric and neurological conditions. * Individuals with irritable bowel syndrome or gastrointestinal disorders. * People with immune disorders or possible immunodeficiency states (e.g. due to surgery). * Use of anti-inflammatory drugs * Use of corticosteroids * People who are allergic to milk, corn starch or soya. * Foreign nationality.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Psychological Well-Being

As listed by the trial registrant

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

Contacts and locations

Locations

  • Istanbul Medipol University

    Istanbul, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.