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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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In this study, the investigators measured the SCFA (Butyrate, Acetate and Propionate) as a Biomarker improvement symptom and quality of life women with functional constipation after supplementation of commensal bacterial fermented milk Lactobacillus plantarum (isolated from indigenous probiotics from Dadih, West Sumatra) for 21 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus plantarum | Experimental | 1 bottle of fermented milk (100 g) containing probiotic Lactobacillus plantarum IS-10506 1.0x10^8 CFU will be given daily for three weeks. |
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| Placebo | Placebo Comparator | 1 bottle of fermented milk (100 g) containing placebo will be given daily for three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum | Drug | Fermented milk containing probiotic Lactobacillus plantarum for three weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Short Chain Fatty Acid (SCFA) titer | Short Chain Fatty Acid (SCFA) titer that will be analyzed by Gas chromatography-mass spectrometry (GCMS) consists of three metabolites:
| Three weeks after intervention |
| Functional constipation symptom improvement (1) | Functional constipation symptom improvement (1) will be measured by improvement of PAC Sym questionnaire score. PAC Sym (Patient Assessment of Constipation Symptoms) has a minimum score of 0, maximum score 48, lower value represents better outcome | Three weeks after intervention |
| Functional constipation symptom improvement (2) | Functional constipation symptom improvement (2) will be measured by improvement of PAC QoL questionnaire score. PAC QoL (Patient Assessment of Constipation Quality of Life) has a minimum score of -20, maximum score 92, lower value represents better outcome | Three weeks after intervention |
| Molecular Profile of Fecal Microbiome | Microbiome profile from faecal samples will be analyzed with NGS (Next Gen Sequencing) method. The result will be analyzed with MiSEq Reporter software (MSR) and will be presented in nM unit measure. | Three weeks after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pratiwi D Kusumo | 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 | Mar 19, 2019 | Prot_SAP_000.pdf |
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| Placebo | Drug | Fermented milk containing placebo for three weeks |
|