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Gut health may help straighten spines: probiotic trial launches

NCT ID NCT07466511

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 daily probiotic supplement (Bifidobacterium breve) can slow the curve progression of idiopathic scoliosis in children aged 6 to 15. One hundred participants will take the probiotic or receive lifestyle education for 6 months. Researchers will measure spine curvature and quality of life to see if the supplement helps.

What this could mean

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

Active substance
Bifidobacterium breve probiotic supplement
What this could lead to
If it works, this could point toward a simple, safe way to slow scoliosis worsening in children, reducing the need for braces or surgery.
What could go wrong
This is a small, early-stage trial with only 100 children. The effect may be small or nonexistent, and results may not apply to all scoliosis patients.

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 100 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

6 to 15 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 6 to 15 years Diagnosed with idiopathic scoliosis based on clinical evaluation and radiographic examination at the first clinic visit Skeletally immature, defined as Risser sign 0 to 3 Major Cobb angle \< 40 degrees at baseline Written informed consent provided by the participant or legal guardian Able and willing to comply with study procedures Exclusion Criteria: * Plans to relocate within the next 24 months Use of antibiotics, probiotics, hormones, immunosuppressants, or other nutritional supplements known to affect gut microbiota within the past 3 months or during the study period without investigator approval Known allergy, sensitivity, or intolerance to the investigational product or its ingredients Current or prior significant gastrointestinal disease requiring medication, or history of gastrointestinal surgery Severe gastrointestinal symptoms such as persistent heartburn or indigestion Musculoskeletal, neurodevelopmental, syndromic, or other conditions that may account for the spinal deformity History of spine surgery or major spinal injury Spinal tumor or malignant disease involving the spine Leg length discrepancy \> 20 mm Severe chronic diseases that could interfere with study participation or outcome assessment, including but not limited to diabetes, narcolepsy, or poorly controlled asthma Severe obesity, defined as BMI z-score ≥ 3

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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.

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

  • The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000

    Wenzhou, Zhejiang, 325600, China

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