The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants

Lallemand Health Solutions180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

180

Conditions

Pregnancy

Interventions

ProbioticDIETARY_SUPPLEMENT

Dosing regimen of one capsule daily for a maximum of 18 weeks

PlaceboOTHER

Dosing regimen of one capsule daily for a maximum of 18 weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinique OVO

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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