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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2022-05-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Combination of two probiotic strains in one capsule

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Non active ingredients in a capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes