Probiotics Alleviate Functional Constipation in Adults

Assessing the Safety and Effectiveness of Bacillus Coagulans BC99 in Relieving Functional Constipation in Adults Based on Randomized, Double-Blind, Placebo-Controlled Trials

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, immunity, and gut microbiota.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan University of Technology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:

   i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:

   1. Straining during more than 25% of defecations
   2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
   3. Sensation of incomplete evacuation more than 25% of defecations
   4. Sensation of anorectal obstruction/blockage more than 25% of defecations
   5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
   6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
2. Able to complete the study according to the requirements of the trial protocol;
3. Patients who have signed the informed consent form;
4. Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.

Only those who meet all the above conditions can be selected for the study. -

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. All participants provided written informed consent. -

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 could take BC99 daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.
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 could take maltodextrin daily and record any adverse reactions. Participants filled out questionnaires and collected stool and serum samples, which were used to detect and analyze the improvement of participants' constipation function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in colonic transit time (CTT) from baseline to 8 weeks	Colonic transit time (hours) was measured by radiolabmarking, and the reduction from baseline was an indicator of effectiveness.	Week 0 and Week 8
Change in Patient Assessment of Constipation Symptoms (PAC-SYM) score from baseline to 8 weeks.	The PAC-SYM questionnaire was used to assess the severity of constipation symptoms (12 items, 0-4 Likert score), with a total score ranging from 0-48 (the lower the score, the milder the symptoms). The magnitude of the decline from the baseline score is an indicator of effectiveness.	Week 0 and Week 8

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2024
• Primary Completion (Actual): October 7, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: WK2024019

Drug and device information, study documents

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