Probiotics for Alleviating Chronic Constipation in Adults

Not Applicable

Completed

• Conditions: Constipation

• Registration Number: NCT07152795
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

To investigate the clinical effects of probiotics in relieving intestinal motility and chronic constipation through regulating gut microbiota.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-30
• Primary Completion: 2024-06-25
• Study Completion: 2024-10-10
• Status Verified: 2025-08
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Chinese adults aged 18-70 years who meet the Rome IV diagnostic criteria for chronic constipation (duration of at least 6 months, with less than 3 bowel movements per week and/or Bristol Stool Scale types 1 and 2);
2. Not using laxatives rarely leads to loose stools；
3. The standard for irritable bowel syndrome is insufficient;
4. Research participants (including male subjects) who have no family planning within 14 days prior to screening and voluntarily take effective contraceptive measures within 6 months after the end of the trial;
5. Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures;
6. Subjects who have signed the informed consent form. -

Exclusion Criteria

(1) The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment; (2) Regular use of a high-fiber diet, as measured by the recommended food score (RFS); (3) Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea; (4) Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon; (5) Medical history of cardiovascular, liver, or renal diseases; alcoholics; (6) Hypersensitivity to probiotics or the ingredients used in this study; (7) Pregnancy or breastfeeding; (8) Participation in another clinical trial in the 3 months before enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.	8 weeks	Constipation symptoms are measured using Bristol Stool Form Scale, where 1 and 2 indicate constipation with hard stools, 3 and 4 show normal conditions with ideal stool form, and 5, 6, and 7 suggest diarrhea with stools becoming softer to watery.

Trial Locations

Locations (1)

Henan University of Science and Technolog; 🇨🇳 Luoyang, Henan, China