AzTrials
AzTrials

PregnancyPhase 2NCT03310853

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

A Phase 2 study testing Probiotic in people with Pregnancy, run by Lallemand Health Solutions at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Probiotic
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteCanada
Study dates
23 Oct 2017to 20 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.)
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Clinique OVO

    Montreal, Quebec

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Pregnancy
Being tested
Probiotic, Placebo
Keywords
probiotics, infections, bacterial vaginosis
Medical subject headings
Infections, Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDietary supplement

    Dosing regimen of one capsule daily for a maximum of 18 weeks

  • PlaceboOther

    Dosing regimen of one capsule daily for a maximum of 18 weeks

Study groups in NCT03310853
Study groupRoleWhat they receive
ProbioticExperimentalCombination of two probiotic strains in one capsule
Receives: Dietary Supplement: Probiotic
PlaceboPlacebo comparatorNon active ingredients in a capsule
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of diagnosed infections in pregnant women

    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.

    Measured: up to 12 weeks

Secondary outcomes (24)

  1. Levels of glucose, insulin, triglycerides and iron

    Assessed via blood sample throughout the pregnancy

    Measured: Measured 2 times up to 12 weeks

  2. Vaginal mycobiota

    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: Measured 3 times up to 18 weeks

  3. Inflammatory markers

    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: Measured up to 3 times in the 18 week time frame

  4. Vaginal microbiota

    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: Measured 3 times up to 18 weeks

  5. Premature rupture of membranes (PROM)

    Incidence of PROM on the probiotic versus the group

    Measured: Measured 1 time at week 12

  6. Levels of secretory immunoglobulin A (sIgA) in the mother

    Assessed via saliva samples throughout pregnancy and a breast milk sample after delivery.

    Measured: Measured up to 4 times in the 18 week time frame

  7. Levels of secretory immunoglobulin A (sIgA) in the infant

    Assessed via stool sample after birth.

    Measured: Measured 1 time up to18 weeks

  8. Gut microbiota in the mother

    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: Measured 3 times up to 18 weeks

  9. Gut microbiota in the infant

    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: Measured 1 time up to 18 weeks

  10. Stool frequency and consistency in the mother

    Assessed with the Bristol Stool Scale

    Measured: Self-reported, daily up to 18 weeks

  11. Stool frequency and pattern in the infant

    Assessed with the Amsterdam Infant Stool Scale

    Measured: Self-reported by the mother, daily up to 4-6 weeks

  12. Weight in the mother

    To assess change in body weight

    Measured: Measured 3 times up to 18 weeks. Pre-pregnancy weight will also be noted via information collection on a demographic questionnaire.

  13. Breast milk microbiota

    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: Measured 1 time up to 18 weeks

  14. Post-Partum Depression

    To be assessed with the Edinburgh Postnatal Depression Scale

    Measured: Measured 2 time up to 18 weeks

  15. Infant's health status - NEC

    To assess the probability of an infant with NEC

    Measured: Measured 1 time up to 18 weeks.

  16. Anthropometric measurements

    Crown-heel length and head circumference

    Measured: Measured 1 time up to 18 weeks. The infant's anthropometric measurements at birth will also be noted.

  17. Weight in the infant

    To assess change in body weight

    Measured: Measured 2 times up to 18 weeks.

  18. Crying time in the infant

    To assess the mean daily crying time of infants

    Measured: Self-reported by the mother, daily up to 4-6 weeks

  19. Colic in the infant

    To asses the probability of an infant with colic

    Measured: Self-reported by the mother, daily up to 4-6 weeks

  20. Sleep in the infant

    Number of total hours and number of consecutive hours

    Measured: Self-reported by the mother, daily up to 4-6 weeks

  21. Number of infections

    To assess the number of infections

    Measured: Self-reported by the mother, daily up to 4-6 weeks

  22. Skin diseases or conditions

    Skin diseases/conditions as well as the child's overall health status 1 year after birth will be assessed.

    Measured: 1 year follow up phone call

  23. Infant's health status - jaundice

    To assess the probability of an infant with jaundice

    Measured: Measured 1 time up to 18 weeks.

  24. Infant's health status - Hyperbilirubinemia

    To assess the probability of an infant with Hyperbilirubinemia

    Measured: Measured 1 time up to 18 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start23 Oct 2017
  3. Primary completion20 May 2022
  4. Study completion20 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310853
Sponsor's protocol ID
MOM study
Status last verified
Feb 2023
First submitted
28 Sep 2017
Last updated
2 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotic in people with Pregnancy, run by Lallemand Health Solutions at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of diagnosed infections in pregnant women (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03310853.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in