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Could a gut bug help kids lose weight? new trial aims to find out

NCT ID NCT07593170

Disease control Sponsor: Central South University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Akkermansia muciniphila (AKK PROBIO) can help obese children and adolescents aged 7 to 18 improve their weight and metabolism. Half of the 100 participants will take the probiotic capsules, and half will take a placebo. The goal is to see if this natural gut bacterium can safely support healthier body weight and metabolic function in young people.

What this could mean

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

Active substance
Akkermansia muciniphila (AKK PROBIO), a pasteurized probiotic
What this could lead to
If it works, this could point toward a safe, natural way to help manage childhood obesity and related metabolic issues.
What could go wrong
This is an early phase 2 trial with only 100 kids, so results may not apply to everyone. The probiotic's effects in children are still unproven, and it may not lead to significant weight loss.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

7 to 18 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 range: 7 years old to 18 years old (inclusive of boundary values), gender not restricted. * Primary obesity: According to the WS/T 586-2018 standard issued by the National Health Commission of China, or the internationally recognized CDC/WHO standard, diagnosed as obesity (if BMI ≥ the 95th percentile of children of the same age and gender). * The subjects and their legal guardians understand the research content, voluntarily participate and sign the written informed consent form (for guardians), and the informed consent form (for children aged 8 years and above). * Able to comply with the research protocol, complete all visits and sample collection. Exclusion Criteria: * Have a definite endocrine disorder causing obesity (such as Cushing's syndrome, hypothyroidism), a genetic syndrome (such as Prader-Willi syndrome), or other known organic diseases. * Have a severe primary disease of the liver, kidney, cardiovascular system, respiratory system or hematopoietic system, etc. * Have used antibiotics, probiotics, prebiotics or synbiotic products within 3 months prior to screening. * Have a history of systemic use of glucocorticoids or other drugs that may affect weight and metabolism (such as metformin, systemic glucocorticoids, diuretics, etc.) within 1 month prior to screening. * Subjects are allergic to any component of the study product (AKK probiotic capsules or placebo). * Subjects are participating in other clinical trials. * Have a history of severe gastrointestinal diseases, such as inflammatory bowel disease (IBD). * Other conditions as determined by the researcher to be unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

Akkermansia muciniphila Obese adolescents Obese children and adolescents Obesity

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

  • Xiangya School of Public Health

    Changsha, Hunan, China

More trials for these conditions

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