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

NCT ID: NCT07002489

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2025-08-24

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 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..

Conditions

Functional Constipation (FC)

Keywords

probiotics; constipation; functional constipation; pre-school children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Notrande Shuhuajun Probiotic Supplement Study Product

Notrande Shuhuajun Probiotic Supplement, Each capsule contains the following active ingredients: ≥79.5 mg of the specially developed formula, 1 × 108 CFU of Lactobacillus fermentum CECT5716, 5 × 109 CFU of Lactobacillus rhamnosus GG, 5 × 109 CFU of Bifidobacterium animalis (Lactobacillus subspecies HNO19), and 1 × 108 CFU of Lactobacillus rhamnosus HNO01.

Group Type: OTHER

Nuotelande Shuhuajun Study Product

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase).

Interventions

Nuotelande Shuhuajun Study Product

Participants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase).

Intervention Type: DIETARY_SUPPLEMENT

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;

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Sibote Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlie Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Raison Biotech Group

Locations

Fuyang Fifth People's Hospital Quanying Branch

Fuyang, Anhui, China

Countries

China

Other Identifiers

25-RD-04-JJ-001

Identifier Type: -

Identifier Source: org_study_id