Probiotics for Alleviating Chronic Constipation in Adults

NCT07152795 | Completed

• 1 other identifier: WK20250825
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.

  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.

  8 weeks

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Probiotic Group

Placebo 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• (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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Science and Technolog

Luoyang, Henan, 462000, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: April 30, 2024
• Primary Completion: June 25, 2024
• Study Completion: October 10, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)