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Completed

NCT Number: NCT03310853

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

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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Key information

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinique OVO

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lallemand Health Solutions

Industry

Collaborators

  • Clinique Ovo

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2017
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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