Probiotics for treating constipation in adults
The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial
This study is testing if a probiotic called ABKefir can help adults with constipation feel better after 8 weeks of treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chung Shan Medical University Academic / other |
| Locations | 1 site (Taichung, South) |
| Trial ID | NCT06969872 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of ABKefir, a probiotic, in alleviating symptoms of functional constipation in adults. A total of 165 participants will be randomly assigned to receive either a placebo, a low dose, or a high dose of ABKefir for 8 weeks. The study includes assessments of defecation patterns, anthropometric measurements, and biological samples at the start, mid-point, and end of the trial. The goal is to determine if probiotics can improve bowel function in individuals suffering from functional constipation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who meet the Rome IV criteria for functional constipation.
Not a fit: Patients with serious underlying health conditions or those on medications that affect bowel function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for adults suffering from functional constipation.
How similar studies have performed: Previous studies have shown promising results for probiotics in managing gastrointestinal symptoms, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female * aged 18-75 years old * fulfill Rome IV criteria for functional constipation * have not participated in similar research in the past three months Exclusion Criteria: * Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease * Irritable bowel syndrome diagnosed during colonoscopy * Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women. * Taking antidepressants, anti-anxiety drugs and other psychotropic drugs. * Long-term medication is required to improve constipation * Those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and/or other serious diseases are not suitable for participating in the study. * Allergic symptoms to probiotics or any ingredients * Having a history of serious mental illness * Drug-related crimes or alcohol problems * Have recently traveled to areas where parasitic diseases are prevalent.
Where this trial is running
Taichung, South
- Chung Shan Medical University — Taichung, South, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hsin-Chi Pan, MS student — Chung Shan Medical University
- Study coordinator: Chin-Lin Hsu, Professor
- Email: clhsu@csmu.edu.tw
- Phone: 04-24730022
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.