Status:
COMPLETED
Probiotics for Alleviating Chronic Constipation in Adults
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Constipation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To investigate the clinical effects of probiotics in relieving intestinal motility and chronic constipation through regulating gut microbiota.
Eligibility Criteria
Inclusion
- 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);
- Not using laxatives rarely leads to loose stools；
- The standard for irritable bowel syndrome is insufficient;
- 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;
- Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures;
- Subjects who have signed the informed consent form. -
Exclusion
- (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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Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07152795
Start Date
April 30 2024
End Date
October 10 2024
Last Update
September 3 2025
Active Locations (1)
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1
Henan University of Science and Technolog
Luoyang, Henan, China, 462000