Status:
COMPLETED
Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children
Lead Sponsor:
Shandong Sibote Biotechnology Co., Ltd.
Conditions:
Functional Constipation (FC)
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT07002489
Start Date
May 30 2025
End Date
August 24 2025
Last Update
December 19 2025
Active Locations (1)
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1
Fuyang Fifth People's Hospital Quanying Branch
Fuyang, Anhui, China