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This randomized, double-blind, placebo-controlled trial will assess the clinical effects of Akk09 in adults with functional constipation. Participants will receive Akk09 or placebo for 4 weeks. The study will evaluate changes in bowel habits and symptom burden, as well as alterations in host inflammatory status, immune modulation, microbial ecosystem dynamics, neuroendocrine signaling related to the gut-brain axis, and systemic metabolic responses, to characterize the overall physiological impact of BC09 supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Participants assigned to this group will be administered Akk09 on a daily basis for 8 weeks. |
|
| Placebo group | Placebo Comparator | Participants in the control group will receive a maltodextrin-based placebo once daily for 8 weeks, identical in appearance and usage to the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Akk09 will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in bowel function | Bowel function will be assessed using the Bristol Stool Form Scale (BSFS), with emphasis on the transition of stool types from harder forms (types 1-2) to softer, more normal forms (types 3-4) during the intervention period. | 8 weeks |
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Inclusion Criteria:
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 | 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 |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Maltodextrin | Dietary Supplement | Maltodextrin will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8. |
|
| D019602 |
| Food and Beverages |