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

Lallemand

Status and phase

Completed

Phase 2

Conditions

Pregnancy

Treatments

Other: Placebo

Dietary Supplement: Probiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT03310853

MOM study

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

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