Actively Recruiting
Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial
Led by Wecare Probiotics Co., Ltd. · Updated on 2025-03-05
84
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how a high-activity probiotic yogurt affects symptoms of chronic constipation. The study also observes how this yogurt influences gut microbiota regulation and monitors any adverse reactions in participants during a 21-day intervention period. The trial involves adults aged 18 to 65 who meet specific diagnostic criteria for chronic constipation. Participants are divided into two groups: one group receives probiotic yogurt containing at least 1000 billion CFUs per bottle, and the other group receives a placebo yogurt. Both groups take one bottle daily for three weeks. The intervention phase includes three visits at week 0, week 1, and week 3 to monitor treatment. During the study, participants undergo assessments to measure improvement in constipation symptoms over three weeks. Researchers also analyze gut microbiota composition and diversity, changes in emotional state, and any effects on weight management. Safety and adherence are monitored throughout the study, which lasts for the full 21-day period.
CONDITIONS
Brief Title
Exploring the Potential Benefits of Probiotic Yogurt
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the Rome IV diagnosis criteria for chronic constipation
- Able to understand the study and comply with its procedures
- Aged between 18 and 65 years
You will not qualify if you...
- Have systemic diseases like diabetes, autoimmune diseases, or cancer
- Have gastrointestinal or liver diseases affecting gut microbiota
- Are pregnant or breastfeeding
- Taken antibiotics, probiotics, or stomach acid/motility drugs in the past 6 weeks
- Changed diet type during the study
- Allergic or intolerant to components of the yogurt
- Have serious cardiovascular, cerebrovascular, liver, kidney, hematopoietic, endocrine, or mental diseases
- Unable to judge efficacy due to stopping study product or adding other drugs during trial
- Used other functional substances affecting results shortly before or during trial
- Dieted, exercised excessively, or used weight loss medications/suppressants in past 3 months
- Excessive current or past use of alcohol, drugs, or supplements affecting intestinal function or study evaluation results -
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 visit (in-person)
Duration - 3 weeks
Participants take one bottle of probiotic or placebo yogurt daily for 3 weeks while making scheduled visits to assess effects.
3 visits (week 0, week 1, and week 3)
Trial Site Locations
Total: 1 location
1
Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University
Suzhou, Jiangsu, China, 215200
Actively Recruiting
Research Team
Y
Ying Jin, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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