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| ID | Type | Description | Link |
|---|---|---|---|
| Sub Grant #IIE-00000078-UI-1 | Other Grant/Funding Number | USAID/SHERA - SMART CITY |
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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Lactobacillus plantarum IS-10506 |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum IS-10506 | Drug | Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement in quality of life | Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.
Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome | Three weeks after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hasan Maulahela, MD | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Petamburan | Jakarta | DKI Jakarta | 11440 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2018 | Feb 1, 2019 | Prot_SAP_000.pdf |
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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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| Placebo | Drug | Fermented milk containing placebo to be consumed once daily for three weeks. |
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