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

This study is currently recruiting participants.
Verified October 2017 by Lallemand Health Solutions
Sponsor:
ClinicalTrials.gov Identifier:
NCT03310853
First Posted: October 16, 2017
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
OVO R & D
Information provided by (Responsible Party):
Lallemand Health Solutions
  Purpose
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.

Condition Intervention Phase
Pregnancy Dietary Supplement: Probiotic Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants: a Randomized, Double-blind, Placebo Controlled Study

Further study details as provided by Lallemand Health Solutions:

Primary Outcome Measures:
  • Number of diagnosed infections in pregnant women [ Time Frame: Measured 6 times 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 Outcome Measures:
  • Levels of glucose, insulin, triglycerides and iron [ Time Frame: Measured 2 times up to 12 weeks ]
    Assessed via blood sample throughout the pregnancy

  • Vaginal mycobiota [ Time Frame: Measured 7 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.

  • Type of delivery [ Time Frame: Measured 1 time at week 12 ]
    A vaginal versus cesarean delivery will be noted

  • 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).

  • Vaginal microbiota [ Time Frame: Measured 7 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.

  • Premature rupture of membranes (PROM) [ Time Frame: Measured 1 time at week 12 ]
    Incidence of PROM on the probiotic versus the group

  • Levels of secretory immunoglobulin A (sIgA) in the mother [ Time Frame: Measured up to 7 times in the 18 week time frame ]
    Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.

  • Levels of secretory immunoglobulin A (sIgA) in the infant [ Time Frame: Measured 1 time up to18 weeks ]
    Assessed via stool sample after birth.

  • 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.

  • 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.

  • Stool frequency and consistency in the mother [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed with the Bristol Stool Scale

  • 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

  • Stress, anxiety and depression levels [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed via daily diary input

  • Headache/Migraine severity [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed via daily diary input

  • Nausea severity [ Time Frame: Self-reported, daily up to 12 weeks ]
    Measured during prenatal period only

  • 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

  • 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.

  • Post-Partum Depression [ Time Frame: Measured 1 time up to 18 weeks ]
    To be assessed with the Edinburgh Postnatal Depression Scale

  • Infant's health status - NEC [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with NEC

  • 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

  • Weight in the infant [ Time Frame: Measured 2 times up to 18 weeks. ]
    To assess change in body weight

  • 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

  • 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

  • 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

  • Number of infections [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the number of infections

  • 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.

  • Infant's health status - jaundice [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with jaundice

  • Infant's health status - Hyperbilirubinemia [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with Hyperbilirubinemia


Estimated Enrollment: 240
Actual Study Start Date: October 23, 2017
Estimated Study Completion Date: October 31, 2020
Estimated Primary Completion Date: October 23, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  • History or current symptoms of depression
  • Maternal history of second trimester loss
  • Women diagnosed HIV Positive or with Hepatitis B or C
  • Known fetal abnormality
  • Plan to deliver by caesarean section
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310853


Contacts
Contact: Sophie Leblanc 514-798-2000 ext 617 s.leblanc@cliniqueovo.com
Contact: Nelly Delouya 514-798-2000 ext 759 n.delouya@cliniqueovo.com

Locations
Canada, Quebec
Clinique OVO Recruiting
Montreal, Quebec, Canada
Contact: Sophie Leblanc    514-798-2000 ext 617    s.leblanc@cliniqueovo.com   
Sponsors and Collaborators
Lallemand Health Solutions
OVO R & D
Investigators
Principal Investigator: Jacques Kadoch, MD OVO R & D
  More Information

Responsible Party: Lallemand Health Solutions
ClinicalTrials.gov Identifier: NCT03310853     History of Changes
Other Study ID Numbers: MOM study
First Submitted: September 28, 2017
First Posted: October 16, 2017
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lallemand Health Solutions:
probiotics
infections
bacterial vaginosis