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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Active Comparator | Bacterial count: ≥1000 billion CFUs per bottle Take one bottle of yogurt per day for 3 weeks |
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| Placebo group | Placebo Comparator | Product name: placebo yogurt Take one bottle of yogurt per day for 3 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic yogurt group | Dietary Supplement | The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3). |
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| Measure | Description | Time Frame |
|---|---|---|
| Constipation symptom improvement | 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:
Therefore, higher scores (closer to 4-6) represent improved constipation symptoms, while lower scores (1-3) indicate more severe constipation. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition and diversity | 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. | 3 weeks |
| Emotional state changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Jin, Doctor | Contact | 13375163966 | sunny13211@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Ninth People's Hospital Suzhou Ninth Hospital affiliated to Soochow University | Recruiting | Suzhou | Jiangsu | 215200 | China |
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| Yogurt control group | Dietary Supplement | The intervention phase of this study will last 3 weeks, and each participant will make 3 visits (week 0, week 1, week 3). |
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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.
| 3 weeks |
| Emotional state changes | Depression Anxiety Stress Scales (DASS) The Depression Anxiety Stress Scales (DASS) will be used to assess changes in participants' emotional state during the study period. The DASS includes three subscales: Depression (DASS-D), Anxiety (DASS-A), and Stress (DASS-S), each containing 14 items. Scoring Range: Each subscale is scored from 0 to 42. Interpretation: Higher scores indicate greater levels of depression, anxiety, or stress. | 3 weeks |
| Weight management impact | Assessing the impact of probiotic yogurt intake on participants' weight management by measuring body weight. | 3 weeks |