The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants
- Conditions
- Pregnancy
- Interventions
- Other: PlaceboDietary Supplement: Probiotic
- Registration Number
- NCT03310853
- Lead Sponsor
- Lallemand Health Solutions
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- Healthy pregnant women
- Less than 28 weeks of gestation (3rd trimester)
- ≥18 to <40 years old
- Singleton gestation
- Availability and willingness to come in for morning visits
- Planning to breastfeed
- Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits
- Willing to discontinue consumption of fermented foods (e.g. foods that contain probiotics such as Kefir, pickles, etc.) or probiotics (e.g. yogurts with live active cultures or probiotic supplements)
- Able to provide informed consent
- Known gestational diabetes or diabetes type 1 or 2
- Known blood/bleeding disorders
- Known liver and kidney disorders
- Known unstable cardiovascular diseases
- Women with a personal history of or currently diagnosed with preeclampsia
- Suffering from neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, epilepsy, etc.)
- Suffering from gastrointestinal diseases (e.g. gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
- Current symptoms of depression or experienced depressive symptoms in the past 2 years
- Maternal history of second trimester loss
- Women diagnosed HIV Positive or with Hepatitis B or C
- Known fetal abnormality
- Daily use of probiotic product within 2 weeks of the screening visit. The potential participant could be eligible to participate after a 2-week wash-out period
- Use of any antibiotic drug within 1 month of screening. The potential participant could be eligible to participate after a 2-week wash-out period
- Smoking, alcohol consumption or drug use during pregnancy
- History of alcohol or substance abuse six months prior to screening
- Allergies to milk, soy, or yeast
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Non active ingredients in a capsule Probiotic Probiotic Combination of two probiotic strains in one capsule
- Primary Outcome Measures
Name Time Method Number of diagnosed infections in pregnant women 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.
- Secondary Outcome Measures
Name Time Method Infant's health status - Hyperbilirubinemia Measured 1 time up to 18 weeks. To assess the probability of an infant with Hyperbilirubinemia
Levels of glucose, insulin, triglycerides and iron Measured 2 times up to 12 weeks Assessed via blood sample throughout the pregnancy
Vaginal mycobiota 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.
Inflammatory markers 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).
Infant's health status - NEC Measured 1 time up to 18 weeks. To assess the probability of an infant with NEC
Stool frequency and pattern in the infant Self-reported by the mother, daily up to 4-6 weeks Assessed with the Amsterdam Infant Stool Scale
Premature rupture of membranes (PROM) Measured 1 time at week 12 Incidence of PROM on the probiotic versus the group
Levels of secretory immunoglobulin A (sIgA) in the mother Measured up to 4 times in the 18 week time frame Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
Levels of secretory immunoglobulin A (sIgA) in the infant Measured 1 time up to18 weeks Assessed via stool sample after birth.
Gut microbiota in the mother 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.
Gut microbiota in the infant 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.
Stool frequency and consistency in the mother Self-reported, daily up to 18 weeks Assessed with the Bristol Stool Scale
Weight in the mother 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
Breast milk microbiota 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.
Post-Partum Depression Measured 2 time up to 18 weeks To be assessed with the Edinburgh Postnatal Depression Scale
Anthropometric measurements Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted. Crown-heel length and head circumference
Weight in the infant Measured 2 times up to 18 weeks. To assess change in body weight
Crying time in the infant Self-reported by the mother, daily up to 4-6 weeks To assess the mean daily crying time of infants
Colic in the infant Self-reported by the mother, daily up to 4-6 weeks To asses the probability of an infant with colic
Sleep in the infant Self-reported by the mother, daily up to 4-6 weeks Number of total hours and number of consecutive hours
Number of infections Self-reported by the mother, daily up to 4-6 weeks To assess the number of infections
Skin diseases or conditions 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.
Vaginal microbiota 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.
Infant's health status - jaundice Measured 1 time up to 18 weeks. To assess the probability of an infant with jaundice
Trial Locations
- Locations (1)
Clinique OVO
🇨🇦Montreal, Quebec, Canada