A Phase 2 interventional study of Probiotic and Placebo in Pregnancy, sponsored by Lallemand Health Solutions. Completed at 1 site in Canada. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Supportive care
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.
Exclusion Criteria:
Combination of two probiotic strains in one capsule
Dietary Supplement: Probiotic
Non active ingredients in a capsule
Other: Placebo
Dosing regimen of one capsule daily for a maximum of 18 weeks
Dosing regimen of one capsule daily for a maximum of 18 weeks
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.
Time frame: up to 12 weeks
Levels of glucose, insulin, triglycerides and iron
Assessed via blood sample throughout the pregnancy
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Measured 3 times up to 18 weeks
Premature rupture of membranes (PROM)
Incidence of PROM on the probiotic versus the group
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured 1 time up to 18 weeks
Stool frequency and consistency in the mother
Assessed with the Bristol Stool Scale
Time frame: Self-reported, daily up to 18 weeks
Stool frequency and pattern in the infant
Assessed with the Amsterdam Infant Stool Scale
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Weight in the mother
To assess change in body weight
Time frame: 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.
Time frame: Measured 1 time up to 18 weeks
Post-Partum Depression
To be assessed with the Edinburgh Postnatal Depression Scale
Time frame: Measured 2 time up to 18 weeks
Infant's health status - NEC
To assess the probability of an infant with NEC
Time frame: Measured 1 time up to 18 weeks.
Anthropometric measurements
Crown-heel length and head circumference
Time frame: 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
Time frame: Measured 2 times up to 18 weeks.
Crying time in the infant
To assess the mean daily crying time of infants
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Colic in the infant
To asses the probability of an infant with colic
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Sleep in the infant
Number of total hours and number of consecutive hours
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Number of infections
To assess the number of infections
Time frame: 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.
Time frame: 1 year follow up phone call
Infant's health status - jaundice
To assess the probability of an infant with jaundice
Time frame: Measured 1 time up to 18 weeks.
Infant's health status - Hyperbilirubinemia
To assess the probability of an infant with Hyperbilirubinemia
Time frame: Measured 1 time up to 18 weeks.
Plan to share: No
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