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| Name | Class |
|---|---|
| International Islamic University Malaysia | OTHER |
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The purpose of this study is to evaluate the effects of oral administration of probiotic at 9 log colony forming unit (CFU)/day on vaginal microbiota profiles compared to placebo via the use of vaginal self-swab microbiota profiling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic 9 log CFU/day | Experimental | Intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic. |
|
| placebo | Placebo Comparator | placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as light-yellow powder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | This project aims to evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire and evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling. |
| Measure | Description | Time Frame |
|---|---|---|
| differences in general women's health | To evaluate differences in general women's health of women on probiotic and placebo via the use of the Women's Health Questionnaire (WHQ) questionnaire containing 37-items covering aspects of anxiety and depression, memory, sleep and sexual issues, on a 4-point Likert scale including some items with reverse scoring, with higher scores indicating poorer health status. | 12 weeks |
| differences in immunity of women | To evaluate differences in immunity of women on probiotic and placebo in terms of blood immunity profiling via measuring concentrations of cytokines such as interleukin (IL)-1b using commercially available ELISA kit. | 12 weeks |
| differences in gut microbiota profiles of women | To evaluate differences in gut microbiota profiles of women on probiotic and placebo via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Syahril Azizan Azha, Doctor | IIUM Kuantan Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Islamic University Malaysia | Kuala Lumpur | Selangor | 50728 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40008414 | Derived | Nisaa AA, Mageswary U, Pei X, Kadir MN, Oon CE, Rajendran D, Tan JJ, Roslan FF, Balasubramaniam SD, Sany S, Ismail EHE, Azizan AS, Liong MT. Probiotic enhanced immunity and mental wellbeing of generally healthy women: a randomised, placebo-controlled and double-blind study. Benef Microbes. 2025 Feb 24;16(4):377-394. doi: 10.1163/18762891-bja00061. |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| 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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A double-blind randomized placebo-controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria.
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The randomization will be performed by the study statistician, who had no contact with the participants. The allocation sequence will not available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
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| placebo | Dietary Supplement | This project aims to evaluate differences in general women's health of women on probiotic and placebo via the use of questionnaire and evaluate differences in immunity of women on probiotic and placebo via blood immunity profiling. To evaluate differences in gut microbiota profiles of women on probiotic and placebo via blood fecal microbiota profiling. |
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| D019602 |
| Food and Beverages |