Chronic Constipation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTProbiotic yogurt group
The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
DIETARY_SUPPLEMENTYogurt control group
The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3).
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Meet the Rome IV diagnosis criteria for chronic constipation; 2. Patients who are able to understand clinical studies and are committed to complying with study requirements and procedures; 3. Age 18-65. -
Exclusion criteria
1. Systemic (diabetes, autoimmune diseases, cancer), gastrointestinal or liver diseases known to be associated with alterations in the gut microbiota; 2. Patients who are pregnant or lactating; 3. have taken antimicrobials, probiotics, or drugs that inhibit stomach acid or gastrointestinal motility in the past 6 weeks; 4. Patients who changed their diet type during the study; 5. Patients who are allergic or intolerant to any component of the investigational product formulation; 6. Patients with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious diseases and endocrine diseases, mental patients; 7. Stop taking the tested sample or add other drugs in the middle, unable to judge the efficacy or incomplete data; 8. short-term use of objects related to the function of the test, affecting the judgment of the result; 9. have been dieting, exercising excessively, taking weight loss medications or taking medications that may affect appetite in the past 3 months; 10. 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constipation symptom improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition and diversity | 3 weeks | Evaluating the changes in the composition and diversity of the gut microbiota before and after the intake of probiotic yogurt using high-throughput sequencing technology. |
| Emotional state changes | 3 weeks | Hospital Anxiety and Depression Scale (HADS) The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in participants' emotional state during the study period. The HADS consists of two subscales: one for anxiety (HADS-A) and one for depression (HADS-D), each containing 7 items. Scoring Range: Each subscale is scored from 0 to 21. Interpretation: Higher scores indicate greater levels of anxiety or depression. |
| Weight management impact | 3 weeks | Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight. |
Countries
China
Contacts
Primary ContactYing Jin, Doctor
Outcome results
None listed