Exploring the Potential Benefits of High-activity Probiotic Yogurt: a Randomized, Double-blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Constipation symptom improvement
Study Overview
Brief Summary
This study aims to evaluate the effect of a high-activity probiotic yogurt on improving symptoms of chronic constipation, observing its regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 21-day intervention period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Meet the Rome IV diagnosis criteria for chronic constipation;
- •Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures;
Exclusion Criteria
- •Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota;
- •Patients who are pregnant or lactating;
- •have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks;
- •Patients who changed their diet type during the study;
- •Patients who are allergic or intolerant to any component of the investigational product formulation;
- •Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients;
- •Stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data;
- •short-term use of objects related to the function of the test, affecting the judgment of the result;
- •have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months;
- •Current or past excessive use of alcohol, drugs, or supplements that may cause intestinal dysfunction or interfere with the evaluation of the efficacy of the study product -
Arms & Interventions
Probiotic group
Bacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks
Intervention: Probiotic yogurt group (Dietary Supplement)
Placebo group
Product name: placebo yogurt Take one bottle of yogurt per day for 3 weeks
Intervention: Yogurt control group (Dietary Supplement)
Outcomes
Primary Outcomes
Constipation symptom improvement
Time Frame: 3 weeks
The Bristol Stool Form Scale (BSFS) will be used to assess improvements in constipation. The BSFS is a 9-point scale ranging from 1 to 7, where higher scores indicate softer stool consistency, approaching a liquid state. The specific scoring is as follows: 1. Separate hard lumps, like nuts (difficult to pass) 2. Sausage-shaped but lumpy 3. Like a sausage but with cracks on the surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear-cut edges (passed easily) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Scores of 4, 5, and 6 are generally considered ideal, indicating smooth bowel movements without constipation. Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation.
Secondary Outcomes
- Emotional state changes(3 weeks)
- Gut microbiota composition and diversity(3 weeks)
- Weight management impact(3 weeks)