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Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children | Clinical Trials | Clareo Health

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

A Single-arm, Open-label Study of Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children Aged 3-6

NCT07002489•Shandong Sibote Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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..

Eligibility

Age

3 - 6 years

Sex

ALL

Healthy Volunteers

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;

Locations (1)

Fuyang Fifth People's Hospital Quanying Branch

Fuyang, Anhui, China

Key Dates

Start Date

May 30, 2025

Primary Completion Date

August 24, 2025

Completion Date

August 24, 2025

Last Updated

December 19, 2025

Enrollment

102

ACTUAL participants

Conditions

Functional Constipation (FC)

Interventions

Nuotelande Shuhuajun Study Product

DIETARY_SUPPLEMENT

COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

NCT07336589

Functional Constipation (FC)

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NOT_YET_RECRUITINGPHASE1/PHASE2

Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features

NCT06506136

Refractory ConstipationSomatic Symptom Disorder (DSM-5)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION

Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features

Baliao Acupoint Stimulation toTreat Functional Constipation