Clinique OVO
Montreal, Quebec, Canada
NCT Number: NCT03310853
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.
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Notify Me18 year–39 year
Female
Interventional
Phase 2
Montreal, Quebec, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dosing regimen of one capsule daily for a maximum of 18 weeks
Dosing regimen of one capsule daily for a maximum of 18 weeks
Time frame: up to 12 weeks
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: Measured 2 times up to 12 weeks
Assessed via blood sample throughout the pregnancy
Time frame: Measured 3 times up to 18 weeks
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 up to 3 times in the 18 week time frame
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 3 times up to 18 weeks
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 1 time at week 12
Incidence of PROM on the probiotic versus the group
Time frame: Measured up to 4 times in the 18 week time frame
Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
Time frame: Measured 1 time up to18 weeks
Assessed via stool sample after birth.
Time frame: Measured 3 times up to 18 weeks
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
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: Self-reported, daily up to 18 weeks
Assessed with the Bristol Stool Scale
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Assessed with the Amsterdam Infant Stool Scale
Time frame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire.
To assess change in body weight
Time frame: Measured 1 time up to 18 weeks
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 2 time up to 18 weeks
To be assessed with the Edinburgh Postnatal Depression Scale
Time frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with NEC
Time frame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted.
Crown-heel length and head circumference
Time frame: Measured 2 times up to 18 weeks.
To assess change in body weight
Time frame: Self-reported by the mother, daily up to 4-6 weeks
To assess the mean daily crying time of infants
Time frame: Self-reported by the mother, daily up to 4-6 weeks
To asses the probability of an infant with colic
Time frame: Self-reported by the mother, daily up to 4-6 weeks
Number of total hours and number of consecutive hours
Time frame: Self-reported by the mother, daily up to 4-6 weeks
To assess the number of infections
Time frame: 1 year follow up phone call
Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.
Time frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with jaundice
Time frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with Hyperbilirubinemia
Lallemand Health Solutions
Industry
The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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