CompletedNot Applicable

Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children

China102 participantsStarted 2025-05-30

Plain-language 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 old). The main questions it aims to answer are: \- Does Notrande Shuhuajun Probiotic Supplement intake improve functional constipation in preschool children? 105 eligible participants will be enrolled in one center and assigned the study product. After one week washout period participants need to take in the product for two weeks, followed by a one-week regression period. Researchers will collect data, analyze data and conclude whether the study product is effective to improve constipation in participants, by comparing the change of concentration of biochemical indicators SCFA (Short-chain fatty acids), Lactobacillus and Bifidobacterium, and visual analysis of Bristol Stool scale etc..

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples

Timeframe: day 0, day 14, and day 21

Change of constipation indicators- Probiotics - Lactobacillus and Bifidobacterium concentration level in the fecal samples

Timeframe: day 0, day 14, and day 21

Trial details

NCT IDNCT07002489

SponsorShandong Sibote Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-24

View on ClinicalTrials.gov More Functional Constipation (FC) trials