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| Name | Class |
|---|---|
| Clinique Ovo | INDUSTRY |
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This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy. In addition, the effect of probiotics intake during pregnancy and breastfeeding on the infant's overall health status will be evaluated.
Throughout pregnancy women undergo many biological changes, including alterations in their microbiota. These infections can exacerbate pregnancy complications and increase the risk of preeclampsia and preterm birth. The present study aims to evaluate the potential effects of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a healthy pregnancy. Potential infections include but are not limited to influenza/colds, bacterial vaginosis, mastitis, candidiasis, urinary tract infection and gingivitis. Additionally, the benefits of probiotic intake by the mother on the infant during pregnancy and breastfeeding will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Combination of two probiotic strains in one capsule |
|
| Placebo | Placebo Comparator | Non active ingredients in a capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Dosing regimen of one capsule daily for a maximum of 18 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of diagnosed infections in pregnant women | This includes any viral, bacterial and fungal infection (e.g. bacterial vaginosis, candidiasis, urinary tract infection, mastitis, cold, flu, gingivitis, etc.). A vaginal swab and saliva sample will be taken at every visit on site throughout pregnancy. The vaginal swab will be used for the detection of Bacterial Vaginosis and Candidiasis. Other required swab samples will be collected if an infection occurs (e.g. vaginal, mouth, throat, nose, etc.). If an infection is suspected by a participant in-between a scheduled visit, the participant will come on site to be checked by a doctor. If the participant is subsequently diagnosed with an infection, a saliva sample will need to be taken at this time. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of glucose, insulin, triglycerides and iron | Assessed via blood sample throughout the pregnancy | Measured 2 times up to 12 weeks |
| Vaginal mycobiota | Vaginal microbiome which includes bacteria, fungus and potentially other eukaryotic micro-organisms such as parasites or viruses. To be assessed with a vaginal swab during pregnancy and after delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Kadoch, MD | Clinique Ovo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique OVO | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
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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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| Placebo |
| Other |
Dosing regimen of one capsule daily for a maximum of 18 weeks |
|
| Measured 3 times up to 18 weeks |
| Inflammatory markers | Assessing levels of both pro- and anti- inflammatory markers in the mother during pregnancy (through stool and blood samples) and after delivery (through breast milk sample). | Measured up to 3 times in the 18 week time frame |
| Vaginal microbiota | Effects of the probiotic interventions on overall microbiota composition in the mother will be assessed. In addition, recovery of the probiotic strains in the vaginal samples will be assessed. | Measured 3 times up to 18 weeks |
| Premature rupture of membranes (PROM) | Incidence of PROM on the probiotic versus the group | Measured 1 time at week 12 |
| Levels of secretory immunoglobulin A (sIgA) in the mother | Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery. | Measured up to 4 times in the 18 week time frame |
| Levels of secretory immunoglobulin A (sIgA) in the infant | Assessed via stool sample after birth. | Measured 1 time up to18 weeks |
| Gut microbiota in the mother | Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed. | Measured 3 times up to 18 weeks |
| Gut microbiota in the infant | Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed. | Measured 1 time up to 18 weeks |
| Stool frequency and consistency in the mother | Assessed with the Bristol Stool Scale | Self-reported, daily up to 18 weeks |
| Stool frequency and pattern in the infant | Assessed with the Amsterdam Infant Stool Scale | Self-reported by the mother, daily up to 4-6 weeks |
| Weight in the mother | To assess change in body weight | Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire. |
| Breast milk microbiota | Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the breast milk samples will be assessed. | Measured 1 time up to 18 weeks |
| Post-Partum Depression | To be assessed with the Edinburgh Postnatal Depression Scale | Measured 2 time up to 18 weeks |
| Infant's health status - NEC | To assess the probability of an infant with NEC | Measured 1 time up to 18 weeks. |
| Anthropometric measurements | Crown-heel length and head circumference | Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted. |
| Weight in the infant | To assess change in body weight | Measured 2 times up to 18 weeks. |
| Crying time in the infant | To assess the mean daily crying time of infants | Self-reported by the mother, daily up to 4-6 weeks |
| Colic in the infant | To asses the probability of an infant with colic | Self-reported by the mother, daily up to 4-6 weeks |
| Sleep in the infant | Number of total hours and number of consecutive hours | Self-reported by the mother, daily up to 4-6 weeks |
| Number of infections | To assess the number of infections | Self-reported by the mother, daily up to 4-6 weeks |
| Skin diseases or conditions | Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed. | 1 year follow up phone call |
| Infant's health status - jaundice | To assess the probability of an infant with jaundice | Measured 1 time up to 18 weeks. |
| Infant's health status - Hyperbilirubinemia | To assess the probability of an infant with Hyperbilirubinemia | Measured 1 time up to 18 weeks. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D019602 |
| Food and Beverages |