Probiotics and Non-Organic Gastrointestinal Improvement

NCT07081100 | Recruiting

• 1 other identifier: WK20250716
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Function

Outcome Measures

Primary Outcomes (1)

• Improvement of gastrointestinal function in study participants

  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.

  4 weeks

Study Arms (1)

Probiotic group

EXPERIMENTAL

Dietary Supplement: Probiotic group

Interventions

Probiotic group DIETARY_SUPPLEMENT

Participants took a freeze-dried probiotic powder every day, half an hour after a meal.

Probiotic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University

Suzhou, Jiangsu, 215200, China

RECRUITING

Central Study Contacts

Ying Jin, Doctor

CONTACT

13375163966; sunny13211@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: August 5, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (1)