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

February 1, 2023 updated by: Lallemand Health Solutions

The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique ovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Probiotic
Combination of two probiotic strains in one capsule
Dietary supplement: Probiotic
Dosing regimen of one capsule daily for a maximum of 18 weeks
PLACEBO_COMPARATOR: Placebo
Non active ingredients in a capsule
Other: Placebo
Dosing regimen of one capsule daily for a maximum of 18 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Levels of glucose, insulin, triglycerides and iron
Time Frame: Measured 2 times up to 12 weeks
Assessed via blood sample throughout the pregnancy
Measured 2 times up to 12 weeks
Vaginal mycobiota
Time Frame: Measured 3 times up to 18 weeks
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.
Measured 3 times up to 18 weeks
Inflammatory markers
Time Frame: Measured up to 3 times in the 18 week time frame
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).
Measured up to 3 times in the 18 week time frame
Vaginal microbiota
Time Frame: Measured 3 times up to 18 weeks
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.
Measured 3 times up to 18 weeks
Premature rupture of membranes (PROM)
Time Frame: Measured 1 time at week 12
Incidence of PROM on the probiotic versus the group
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
Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.
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
Assessed via stool sample after birth.
Measured 1 time up to18 weeks
Gut microbiota in the mother
Time Frame: Measured 3 times up to 18 weeks
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
Measured 3 times up to 18 weeks
Gut microbiota in the infant
Time Frame: Measured 1 time up to 18 weeks
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the stool samples will be assessed.
Measured 1 time up to 18 weeks
Stool frequency and consistency in the mother
Time Frame: Self-reported, daily up to 18 weeks
Assessed with the Bristol Stool Scale
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
Assessed with the Amsterdam Infant Stool Scale
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.
To assess change in body weight
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
Effects of the probiotic interventions on overall microbiota composition will be assessed. In addition, recovery of the probiotic strains in the breast milk samples will be assessed.
Measured 1 time up to 18 weeks
Post-Partum Depression
Time Frame: Measured 2 time up to 18 weeks
To be assessed with the Edinburgh Postnatal Depression Scale
Measured 2 time up to 18 weeks
Infant's health status - NEC
Time Frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with NEC
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.
Crown-heel length and head circumference
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.
To assess change in body weight
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
To assess the mean daily crying time of infants
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
To asses the probability of an infant with colic
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 total hours and number of consecutive hours
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
To assess the number of infections
Self-reported by the mother, daily up to 4-6 weeks
Skin diseases or conditions
Time Frame: 1 year follow up phone call
Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.
1 year follow up phone call
Infant's health status - jaundice
Time Frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with jaundice
Measured 1 time up to 18 weeks.
Infant's health status - Hyperbilirubinemia
Time Frame: Measured 1 time up to 18 weeks.
To assess the probability of an infant with Hyperbilirubinemia
Measured 1 time up to 18 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lallemand Health Solutions

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinique Ovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOM study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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