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The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vaginal Microbiome, 16S rRNA | Baseline, and 4-6 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rectal Microbiome, 16S rRNA | Baseline, and 4-6 weeks after intervention | |
| Change in Urinary Microbiome, 16S rRNA | Baseline, and 4-6 weeks after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD, La Jolla Clinic, 8910 Villa La Jolla Drive | La Jolla | California | 92037 | United States | ||
| UCSD, Hillcrest Clinic, Medical Offices South |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 31, 2019 | |
| Reset | Jan 14, 2020 | |
| Release | Apr 13, 2020 | |
| Reset | Apr 22, 2020 | |
| Release | Nov 16, 2020 | |
| Reset | Dec 9, 2020 | |
| Release | Feb 2, 2022 | |
| Unrelease | Feb 2, 2022 | |
| Release | Mar 8, 2022 | |
| Reset | Jun 6, 2022 | |
| Release | Jan 16, 2024 | |
| Reset | Jun 28, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 31, 2019 | Jan 14, 2020 | |||
| Apr 13, 2020 |
| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Placebo, taken by mouth once daily for 4-6 weeks. |
|
| San Diego |
| California |
| 92103 |
| United States |
| UCSD, Sorrento Valley Clinic, Directors Place | San Diego | California | 92121 | United States |
| Apr 22, 2020 |
| Nov 16, 2020 | Dec 9, 2020 |
| Feb 2, 2022 | Feb 2, 2022 |
| Mar 8, 2022 | Jun 6, 2022 |
| Jan 16, 2024 | Jun 28, 2024 |
| D019602 |
| Food and Beverages |