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

• ClinicalTrials.gov Identifier: NCT03310853
• Recruitment Status: Completed
• First Posted: October 16, 2017
• Last Update Posted: February 2, 2023
• Sponsor: Lallemand Health Solutions
• Collaborator: Clinique Ovo
• Information provided by (Responsible Party): Lallemand Health Solutions

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy	Dietary Supplement: Probiotic; Other: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 180 participants
• 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
• Actual Study Start Date: October 23, 2017
• Actual Primary Completion Date: May 20, 2022
• Actual Study Completion Date: May 20, 2022

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Levels of glucose, insulin, triglycerides and iron [ Time Frame: Measured 2 times up to 12 weeks ]
   Assessed via blood sample throughout the pregnancy
2. 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.
3. 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).
4. 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.
5. Premature rupture of membranes (PROM) [ Time Frame: Measured 1 time at week 12 ]
   Incidence of PROM on the probiotic versus the group
6. 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.
7. Levels of secretory immunoglobulin A (sIgA) in the infant [ Time Frame: Measured 1 time up to18 weeks ]
   Assessed via stool sample after birth.
8. 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.
9. 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.
10. Stool frequency and consistency in the mother [ Time Frame: Self-reported, daily up to 18 weeks ]
    Assessed with the Bristol Stool Scale
11. 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
12. 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
13. 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.
14. Post-Partum Depression [ Time Frame: Measured 2 time up to 18 weeks ]
    To be assessed with the Edinburgh Postnatal Depression Scale
15. Infant's health status - NEC [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with NEC
16. 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
17. Weight in the infant [ Time Frame: Measured 2 times up to 18 weeks. ]
    To assess change in body weight
18. 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
19. 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
20. 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
21. Number of infections [ Time Frame: Self-reported by the mother, daily up to 4-6 weeks ]
    To assess the number of infections
22. 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.
23. Infant's health status - jaundice [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with jaundice
24. Infant's health status - Hyperbilirubinemia [ Time Frame: Measured 1 time up to 18 weeks. ]
    To assess the probability of an infant with Hyperbilirubinemia

Eligibility Criteria

• 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.)
• 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

Contacts and Locations

Locations

Canada, Quebec

Clinique OVO

Montreal, Quebec, Canada

Sponsors and Collaborators

Lallemand Health Solutions

Clinique Ovo

Investigators

• Principal Investigator: Jacques Kadoch, MD; Clinique Ovo

More Information

• Responsible Party: Lallemand Health Solutions
• ClinicalTrials.gov Identifier: NCT03310853
• Other Study ID Numbers: MOM study
• First Posted: October 16, 2017
• Last Update Posted: February 2, 2023
• Last Verified: February 2023

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