Clinical trial NCT03310853: The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants
Official title: The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy
Keywords: probiotics
infections
bacterial vaginosis
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: Clinique Ovo
First posted: 2017-10-16
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of diagnosed infections in pregnant women
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Levels of glucose, insulin, triglycerides and iron
timeFrame: Measured 2 times up to 12 weeks
measure: Vaginal mycobiota
timeFrame: Measured 3 times up to 18 weeks
measure: Inflammatory markers
timeFrame: Measured up to 3 times in the 18 week time frame
measure: Vaginal microbiota
timeFrame: Measured 3 times up to 18 weeks
measure: Premature rupture of membranes (PROM)
timeFrame: Measured 1 time at week 12
measure: Levels of secretory immunoglobulin A (sIgA) in the mother
timeFrame: Measured up to 4 times in the 18 week time frame
measure: Levels of secretory immunoglobulin A (sIgA) in the infant
timeFrame: Measured 1 time up to18 weeks
measure: Gut microbiota in the mother
timeFrame: Measured 3 times up to 18 weeks
measure: Gut microbiota in the infant
timeFrame: Measured 1 time up to 18 weeks
measure: Stool frequency and consistency in the mother
timeFrame: Self-reported, daily up to 18 weeks
measure: Stool frequency and pattern in the infant
timeFrame: Self-reported by the mother, daily up to 4-6 weeks
measure: Weight in the mother
timeFrame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire.
measure: Breast milk microbiota
timeFrame: Measured 1 time up to 18 weeks
measure: Post-Partum Depression
timeFrame: Measured 2 time up to 18 weeks
measure: Infant's health status - NEC
timeFrame: Measured 1 time up to 18 weeks.
measure: Anthropometric measurements
timeFrame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted.
measure: Weight in the infant
timeFrame: Measured 2 times up to 18 weeks.
measure: Crying time in the infant
timeFrame: Self-reported by the mother, daily up to 4-6 weeks
measure: Colic in the infant
timeFrame: Self-reported by the mother, daily up to 4-6 weeks
measure: Sleep in the infant
timeFrame: Self-reported by the mother, daily up to 4-6 weeks
measure: Number of infections
timeFrame: Self-reported by the mother, daily up to 4-6 weeks
measure: Skin diseases or conditions
timeFrame: 1 year follow up phone call
measure: Infant's health status - jaundice
timeFrame: Measured 1 time up to 18 weeks.
measure: Infant's health status - Hyperbilirubinemia
timeFrame: Measured 1 time up to 18 weeks.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique OVO
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References: