Gut bacteria may hold key to weight loss — trial puts probiotic to the test

NCT ID NCT06140641

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether a daily probiotic supplement called Bifidobacterium longum BL21 can help overweight or obese adults lower their body mass index (BMI) and improve metabolic health. Over 8 weeks, participants take either the probiotic or a placebo, and researchers track changes in gut bacteria, BMI, and other health markers through blood, urine, and stool samples. The goal is to see if this specific probiotic can positively influence weight and metabolism.

What this could mean

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

Active substance
a probiotic supplement called Bifidobacterium longum BL21
What this could lead to
If it works, this could point toward a simple, natural way to support weight management and metabolic health in people who are overweight or obese.
What could go wrong
This is a small, early-stage trial with only 72 participants. The probiotic may have little to no effect on weight or metabolism, and results may not apply to everyone.

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

72 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 2024

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

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. Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity; 2. Willing to take the test formulation daily during the study period; 3. Subjects who understand clinical research and commit to complying with research requirements and procedures. Exclusion Criteria: 1. Patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications; 2. Patients with severe allergies and immune deficiencies; 3. Pregnant, breastfeeding, or expectant women during the study period 4. Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.); 5. Have a history of intervention with lipid-lowering drugs or health products within the past 2 months; 6. Individuals who have used antibiotics within the past two weeks; 7. Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy 8. Subjects deemed unsuitable by other researchers to participate.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Qilu hospital

    Jinnan, Shandong, 250012, China