Probiotics and Non-Organic Gastrointestinal Improvement

Not Applicable

Recruiting

• Conditions: Gastrointestinal Function

• Registration Number: NCT07081100
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

To verify the improvement of gastrointestinal function in patients with non-organic gastrointestinal dysfunction after 4 weeks of intervention with compound probiotics.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-31
• Study Start: 2025-08-05
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Voluntarily sign the informed consent form and agree to participate in the study.
• Ability to complete the study according to the trial protocol requirements.
• Aged 18-65 years.
• Clinical diagnosis of non-organic gastrointestinal dysfunction (e.g., functional dyspepsia, functional constipation) without other serious organic diseases.

Exclusion Criteria

• Use of drugs affecting intestinal flora (antibiotics, probiotics, intestinal mucosal protectants, herbal medicines, etc.) for >1 week within 1 month prior to screening.
• Short-term use of products with functions similar to the investigational product, which may interfere with result interpretation.
• Antibiotic use during the study period.
• History of severe systemic diseases or malignancies.
• Allergy to any ingredient in the compound probiotic freeze-dried powder used in the trial.
• Pregnancy, lactation, or plans for pregnancy in the near future.
• Inability to participate due to personal reasons.
• Other conditions deemed unsuitable by the investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Improvement of gastrointestinal function in study participants	4 weeks	The severity of gastrointestinal symptoms was assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Each item is scored from 1 (no symptoms) to 7 (extremely severe symptoms. Higher scores indicate worse gastrointestinal dysfunction.

Trial Locations

Locations (1)

Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University; 🇨🇳 Suzhou, Jiangsu, China