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To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Experimental | Taking 60 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. |
|
| Placebo Group | Placebo Comparator | Take 3g of maltodextrin daily; the product packaging is the same as that of probiotic products. |
|
| High-activity probiotic group | Experimental | Taking 300 billion CFU of Lactobacillus plantarum Lp18 daily; Storage: Store in a cool, dry palce without sun expouse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of constipation symptoms | Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool). | 8 weeks |
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Inclusion Criteria:
(1) Age 18-65 years; (2) Constipated patients (less than 3 bowel movements per week and/or Bristol Scale type 1 and 2); (3) Able to complete the study according to the trial protocol; (4) Patients who have signed the informed consent form; (5) Study participants (including male study participants) have no plans to have children within 14 days prior to screening and within 6 months after the end of the trial and voluntarily use effective contraception.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Jin | Contact | 18336086291 | 1959643812@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Ninth People's Hospital | Recruiting | Suzhou | Jiangsu | 215000 | 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 |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. |
|
| High-activity probiotic probiotic | Dietary Supplement | The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8. |
|
| D019602 |
| Food and Beverages |