Probiotics for Alleviating Chronic Constipation in Adults

Wecare Probiotics

Status: Completed

Conditions: Constipation

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07152795

WK20250825

Details and patient eligibility

About

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Probiotic Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo