Probiotics for Alleviating Chronic Constipation in Adults

NCT ID: NCT07152795

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-10-10

Brief Summary

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

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Group

Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Placebo Group

Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Interventions

Probiotic

During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Science and Technolog

Luoyang, Henan, China

Countries

China

Other Identifiers

WK20250825

Identifier Type: -

Identifier Source: org_study_id