Probiotic treatment for functional constipation
Efficacy of Probiotic in Patients With Functional Constipation
This study is testing if probiotics can help adults with functional constipation feel better and have more regular bowel movements.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Deyang, Sichuan and 1 other locations) |
| Trial ID | NCT06122558 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of probiotics in improving gut microbiota and alleviating symptoms of functional constipation in adults aged 18 to 81. The study focuses on patients who experience difficulty in defecation and reduced bowel movement frequency, which significantly impacts their quality of life. Participants will be randomly assigned to receive either the probiotic treatment or a placebo, allowing for a comparison of outcomes. The study aims to provide insights into a potential non-pharmacological treatment option for this common condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 81 who meet the diagnostic criteria for functional constipation as per the Rome IV guidelines.
Not a fit: Patients with refractory constipation or those whose constipation is caused by neurological, metabolic, or obstructive diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for managing functional constipation without the need for laxatives.
How similar studies have performed: Previous studies have shown promising results with probiotics for gastrointestinal issues, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for functional constipation in the Rome IV * Ruled out for IBS or secondary constipation Exclusion Criteria: * Diagnosed with refractory constipation * Any other constipation caused by neurological diseases, metabolic diseases, obstructive diseases and drugs * Mental illness * Immunodeficiency diseases or used immunosuppressants, serious diseases of the heart, brain, kidney and other systems, malignant tumors, intestinal perforation, intestinal obstruction, intestinal bleeding * Currently using antibiotics or have a history of taking antibiotics in the past 4 weeks. * Participating in other clinical trials
Where this trial is running
Deyang, Sichuan and 1 other locations
- Deyang People's Hospital — Deyang, Sichuan, China (Recruiting)
- School of Industrial Technology, Universiti Sains Malaysia — Pulau Pinang, Penang, Malaysia (Not_yet_recruiting)
Study contacts
- Principal investigator: Min Liong, PhD — Universiti Sains Malaysia
- Study coordinator: Min Tze Liong, PhD
- Email: mintze.liong@usm.my
- Phone: 046532114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.