Can a probiotic help constipated kids? new study says maybe

NCT ID NCT07002489

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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 Results may not be published yet.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
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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.

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First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested whether a probiotic supplement called Notrande Shuhuajun can improve constipation in children aged 3 to 6. Over 100 kids took the supplement for two weeks, and researchers checked changes in gut bacteria and stool consistency. The goal was to see if the probiotic helps ease symptoms of functional constipation.

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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

102 people

The number who actually took part.

Started

May 2025

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 6 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: * Participants must be preschool children (aged 3-6); * Participants were diagnosed with functional constipation based on Rome IV criteria; * Participants agreed not to take any drugs, supplements, or other dairy products during the trial period; * Participants agreed not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt beverages during the trial period; * Be willing to refrain from participating in other interventional clinical studies during the trial period; * Be able to fully understand the nature, purpose, benefits obtained, as well as possible risks and side effects of this study; * Be willing to comply with all test requirements and procedures; * Sign the informed consent form; Exclusion Criteria: * In the treatment of gastrointestinal symptoms; * Lactose intolerance; * Currently suffering from other organic diseases that affect intestinal function, such as a history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc; * Have been controlling diet, increasing exercise, or taking drugs to control weight or affect appetite in the last three months; * Have any of the following medical histories or have been clinically diagnosed with any of the following diseases that may affect the evaluation of the trial effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; * Current or past abuse of alcohol or other prohibited drugs, supplements or OTC prescription drugs may cause intestinal dysfunction or affect the evaluation of the test results; * According to the researchers' judgment, drugs that may affect gastrointestinal function or the immune system are currently being frequently used; * Laxatives or other digestive AIDS were used two weeks before the start of the trial; * Have consumed dairy products or other foods containing prebiotics/bacteria 10 days before the start of the trial; * The research doctors believed that the volunteers could not fully cooperate with the trial arrangements;

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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

  • Fuyang Fifth People's Hospital Quanying Branch

    Fuyang, Anhui, China

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