NCT07002489

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Shandong Sibote Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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).

Timeline

• Start date: 2025-05-30
• Primary completion: 2025-08-24
• Completion: 2025-08-24
• First posted: 2025-06-03
• Last updated: 2025-12-19

Locations

1 site across 1 country: China