Probiotic for Alleviating Functional Constipation in Adults

Weizmannia Coagulans BC99 Improved Intestinal Motility and Chronic Constipation Through Regulating Gut Microbiota: a Randomized, Double-blind, Placebo-controlled Trial

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function and gut microbiota.

Study Overview

• Status: Completed
• Conditions: Con; Cons ti; Con s ti
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • The School of Food and Bioengineering, Henan University of Science and Technolog

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 three passing stools per week and/or Bristol Stool Scale types 1 and 2); (2) The patient rarely experiences diarrhea without using laxatives; (3) The criteria for irritable bowel syndrome were insufffcient ; (4) patients that could complete the study according to the requirements of the trial protocol; (5) 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; (6) Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures; (7) Subjects who have signed the informed consent form. Only those who meet all the above conditions can be selected for the study.

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Exclusion Criteria:

1. Use of probiotics, prebiotics, or antibiotics within two weeks prior to enrollment and throughout the intervention period;
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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Group; Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).	Dietary supplement: 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.
Placebo Comparator: Placebo Group; Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.	Constipation symptoms are measured using Bristol Stool Form Scale, which classifies stool into seven types (1-2 indicate constipation, 3-4 normal, and 5-7 diarrhea) for self-assessment or clinical evaluation of bowel function.	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: WK20260611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No