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To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Every day to Pediococcus acidilactici PA53 (30 billion CFU/day, 3g) intervention, for 8 weeks. Store in a cool and dry place. |
|
| Placebo | Placebo Comparator | Every day to give 3 g maltodextrin intervention for 8 weeks. Store in a cool and dry place. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constipation symptom improvement | Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics. | 8 weeks |
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Inclusion Criteria:
1. Constipated subjects Subjects (less than 3 bowel movements per week and/or Bristol Scale Types 1 and 2); 2. Be able to complete the research according to the requirements of the test plan; 3. Subjects who have signed informed consent; 4. Subjects (including male subjects) have no family planning and voluntarily take effective contraceptive measures from 14 days before screening to 6 months after the end of the trial.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuhan xia, Doctor | Contact | 18336086291 | 1959643812@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | China |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Maltodextrin | Dietary Supplement | The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8). |
|
| D019602 |
| Food and Beverages |