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A randomised, double-blind, placebo-control trial, to assess the safety and effectiveness of Bacillus coagulans BC99 in the relief from chronic constipation

A randomised, double-blind, placebo-control trial, to assess the safety and effectiveness of Bacillus coagulans BC99 in the relief from chronic constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065493
Enrollment
Unknown
Registered
2022-11-07
Start date
2022-11-20
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic constipation

Interventions

Probiotics intervention group:Probiotics

Sponsors

Suzhou Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients will be considered eligible for study participation if they meet the following inclusion criteria: 1. Male and female subjects, aged 18-65 years; 2. Meet the Rome IV diagnostic criteria; 3. Patients with chronic constipation (disease duration more than 6 months, less than 3 bowel movements per week and/or Bristol scale types 1 and 2); 4. Patients who understand clinical research and are committed to complying with study requirements and procedures; 5. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: Patients will not be eligible for study enrollment if they have one or more of the following criteria: 1. Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or hepatic diseases known to be associated with alterations in the gut microbiota; 2. Pregnant or lactating patients; 3. The patient has taken antimicrobials, probiotics, or drugs that inhibit gastric acid or gastrointestinal motility in the past 6 weeks; 4. Patients who changed their diet type during the study; 5. Patients who are allergic to or intolerant to any ingredient in the preparation of the study product; 6. Patients with serious diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, endocrine diseases and mental diseases; 7. Stop taking the test sample or take other drugs in the middle of the course, and the efficacy cannot be judged or the data are incomplete; 8. In a short period of time, taking items related to the test function will affect the judge of the results; 9. In the investigator's judgment, the subject's condition does not qualify him or her to participate in the study.

Design outcomes

Primary

MeasureTime frame
Improve the symptoms of chronic constipation;

Secondary

MeasureTime frame
Patient Assessment of Constipation Symptom (PAC-SYM) and Patient Assessment of Constipation Quality of Life (PAC-QoL) of patients were evaluated by questionnaire;To evaluate the effect of probiotics on intestinal flora in patients with chronic constipation;To evaluate the effect of probiotics administration on other clinical parameters;Serological indicators of the determination of concentrations, including IL-6;

Countries

China

Contacts

Public ContactYing Jin

Suzhou Ninth People's Hospital

sunny13211@sina.com+86 13375163966

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026