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This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Akk11 | Experimental | Healthy Subjects Receiving Probiotic live Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion AFU/capsule). Store in cool and dry place, without exposure to light. |
|
| Inactivated Akk11 | Experimental | Healthy Subjects Receiving Probiotic Inactivated Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion TFU/capsule). Store in cool and dry place, without exposure to light. |
|
| Placebo | Placebo Comparator | Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in stool quality | Stool consistency (using the Bristol Stool Scale) from baseline to day 30. The Bristol Stool Scale is a tool to assess gut health by classifying feces into seven categories based on shape and consistency: types 1-2 indicate constipation, 3-4 are normal, and 5-7 suggest diarrhea. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicky Achmad Ginanjar, bachelor | Contact | +62 21 7695513, 7515932 | +62 | vicky.achmad@equilab-int.com |
| Natalina Soesilawati, Dr | Contact | 0217695513 | ec_fkui@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Recruiting | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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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 30 days and each patient will make 3 visits (d1,d15,d30). |
|
| D019602 |
| Food and Beverages |