Actively Recruiting
The Effects of ABKefir on Functional Constipation: A Randomized, Double-blind, Placebo-controlled Trial
Led by Chung Shan Medical University · Updated on 2026-01-02
165
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chung Shan Medical University
Lead Sponsor
S
SYNBIO TECH INC. Kaohsiung Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of ABKefir probiotics on adults with functional constipation to see if taking one capsule daily can improve constipation symptoms. This randomized, double-blind, placebo-controlled clinical trial involves 165 adults aged 18 to 75 who meet specific criteria for functional constipation. The trial aims to assess changes in constipation symptoms over an eight-week period. Participants will be randomly assigned to one of three groups: a placebo group, a low-dose ABKefir group taking 5 x 10^9 CFU per capsule, or a high-dose ABKefir group taking 1 x 10^10 CFU per capsule. For the first four weeks, subjects take one capsule daily within 30 minutes after breakfast. After this period, there is a four-week follow-up phase without supplementation. Throughout the study, participants will have assessments at the start, week 4, and week 8, including body measurements, defecation questionnaires, food records, and collections of feces and blood samples. Researchers will measure changes in constipation symptoms from baseline at weeks 4 and 8 to evaluate the impact of the probiotic treatment.
CONDITIONS
Brief Title
Effects of Probiotics on Symptoms of Constipation in Adults With Functional Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Aged 18 to 75 years old
- Meet Rome IV criteria for functional constipation
- Have not participated in similar research in the past three months
You will not qualify if you...
- Personal or family history of colon cancer, celiac disease, or inflammatory bowel disease
- Diagnosis of irritable bowel syndrome during colonoscopy
- Currently pregnant, recently pregnant, or breastfeeding
- Taking antidepressants, anti-anxiety, or other psychotropic drugs
- Require long-term medication to improve constipation
- Diagnosed with myocardial infarction, cerebral infarction, malignant tumor, or other serious diseases
- Allergic to probiotics or any ingredients
- History of serious mental illness
- History of drug-related crimes or alcohol problems
- Recently traveled to areas where parasitic diseases are common
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants take one capsule of either placebo or ABKefir probiotic daily for 4 weeks.
3 visits at Week 0, Week 2, and Week 4 for assessments
Duration - 4 weeks
Participants do not take supplements and complete assessments to monitor symptoms for 4 weeks after treatment.
2 visits at Week 4 and Week 8 for assessments
Trial Site Locations
Total: 1 location
1
Chung Shan Medical University
Taichung, South, Taiwan, 402
Actively Recruiting
Research Team
C
Chin-Lin Hsu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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