Clinical trial NCT07002489: Efficacy of Notrande Shuhuajun Probiotic & Mushroom Dietary Supplement on Improving Constipation in Preschool Children
Official title: A Single-arm, Open-label Study of Efficacy of Notrande Shuhuajun Probiotic & Mushroom Dietary Supplement on Improving Functional Constipation in Preschool Children Aged 3-6
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Constipation (FC)
Keywords: probiotics
constipation
functional constipation
pre-school children
Lead sponsor: Shandong Sibote Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-03
Enrollment: 105
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic \& Mushroom Dietary Supplement (Notrande Shuhuajun for short) 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 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..


Eligibility criteria: 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;

Primary outcomes:
measure: Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples
timeFrame: day 0, day 14, and day 21
measure: Change of constipation indicators- Probiotics - Lactobacillus and Bifidobacterium concentration level in the fecal samples
timeFrame: day 0, day 14, and day 21
Secondary outcomes:
measure: Change of Bristol Stool Form Scale (BSFS)
timeFrame: day 0 , day 21
Other outcomes:
Locations:
Study officials:
affiliation: Raison Biotech Group
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: