Can a probiotic help constipated kids? new study says maybe
NCT ID NCT07002489
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
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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
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102 people
The number who actually took part.
- Started
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May 2025
- Finished
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Aug 2025
- Lead sponsor
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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
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3 to 6 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Fuyang Fifth People's Hospital Quanying Branch
Fuyang, Anhui, China
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Other studies related to the condition(s) this trial covers.
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