---
title: The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants
nct_id: NCT03310853
overall_status: COMPLETED
phase: PHASE2
sponsor: Lallemand Health Solutions
study_type: INTERVENTIONAL
primary_condition: Pregnancy
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03310853.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03310853"
ct_last_update_post_date: 2023-02-02
last_seen_at: "2026-05-12T06:25:41.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03310853](https://clinicaltrials.gov/study/NCT03310853)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 180
- **Lead Sponsor:** Lallemand Health Solutions
- **Collaborators:** Clinique Ovo
- **Conditions:** Pregnancy
- **Start Date:** 2017-10-23
- **Completion Date:** 2022-05-20
- **CT.gov Last Update:** 2023-02-02

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 39 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Probiotic** (EXPERIMENTAL) — Combination of two probiotic strains in one capsule
- **Placebo** (PLACEBO_COMPARATOR) — Non active ingredients in a capsule

## Interventions

- **Probiotic** (DIETARY_SUPPLEMENT) — Dosing regimen of one capsule daily for a maximum of 18 weeks
- **Placebo** (OTHER) — Dosing regimen of one capsule daily for a maximum of 18 weeks

## Primary Outcomes

- **Number of diagnosed infections in pregnant women** _(time frame: 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 Outcomes

- **Levels of glucose, insulin, triglycerides and iron** _(time frame: Measured 2 times up to 12 weeks)_
- **Vaginal mycobiota** _(time frame: Measured 3 times up to 18 weeks)_
- **Inflammatory markers** _(time frame: Measured up to 3 times in the 18 week time frame)_
- **Vaginal microbiota** _(time frame: Measured 3 times up to 18 weeks)_
- **Premature rupture of membranes (PROM)** _(time frame: Measured 1 time at week 12)_
- **Levels of secretory immunoglobulin A (sIgA) in the mother** _(time frame: Measured up to 4 times in the 18 week time frame)_
- **Levels of secretory immunoglobulin A (sIgA) in the infant** _(time frame: Measured 1 time up to18 weeks)_
- **Gut microbiota in the mother** _(time frame: Measured 3 times up to 18 weeks)_
- **Gut microbiota in the infant** _(time frame: Measured 1 time up to 18 weeks)_
- **Stool frequency and consistency in the mother** _(time frame: Self-reported, daily up to 18 weeks)_
- **Stool frequency and pattern in the infant** _(time frame: Self-reported by the mother, daily up to 4-6 weeks)_
- **Weight in the mother** _(time frame: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire.)_
- **Breast milk microbiota** _(time frame: Measured 1 time up to 18 weeks)_
- **Post-Partum Depression** _(time frame: Measured 2 time up to 18 weeks)_
- **Infant's health status - NEC** _(time frame: Measured 1 time up to 18 weeks.)_
- **Anthropometric measurements** _(time frame: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted.)_
- **Weight in the infant** _(time frame: Measured 2 times up to 18 weeks.)_
- **Crying time in the infant** _(time frame: Self-reported by the mother, daily up to 4-6 weeks)_
- **Colic in the infant** _(time frame: Self-reported by the mother, daily up to 4-6 weeks)_
- **Sleep in the infant** _(time frame: Self-reported by the mother, daily up to 4-6 weeks)_
- **Number of infections** _(time frame: Self-reported by the mother, daily up to 4-6 weeks)_
- **Skin diseases or conditions** _(time frame: 1 year follow up phone call)_
- **Infant's health status - jaundice** _(time frame: Measured 1 time up to 18 weeks.)_
- **Infant's health status - Hyperbilirubinemia** _(time frame: Measured 1 time up to 18 weeks.)_

## Locations (1)

- Clinique OVO, Montreal, Quebec, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clinique ovo|montreal|quebec|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03310853.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03310853*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*