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

NCT07002489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-12-19

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Shandong Sibote Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Charlie Zhang, MD · Raison Biotech Group

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2025-08-24
Completion
2025-08-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002489 on ClinicalTrials.gov