In Utero Drug ExposurePhase 2PROBIONCT04050189
Validation of the In-utero Transmission of Probiotics
A Phase 2 study testing Natural products: Probiotics in people with In Utero Drug Exposure, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial summary
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Utero Drug Exposure
- What is being tested?
- Natural products: Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2022to 28 Nov 2023
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a single pregnancy
- Women with a low risk pregnancy
- Women wishing to breastfeed at birth
- Women randomized between 32 0/7 - 33 6/7 weeks of gestation
Who cannot join
- History of obstetric complications (prematurity <37 weeks, preeclampsia , gestational diabetes treated with insulin)
- Obstetric or fetal complications known for current pregnancy such as threaten preterm labor (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or anomalies, corticosteroid therapy
- Risk factors for obstetric complications during current pregnancy such as gestational diabetes, type I / II diabetes and high blood pressure (systole ≥140 and diastole ≥90)
- Antibiotic use within 2 weeks before randomisation
- Intake of probiotics or foods enriched with active cultures (fermented milk, kefir, kombucha ...) within 2 weeks before randomisation
- Women positive for Group B Streptococcus during previous pregnancies
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- Weakened immune system (AIDS, lymphoma, chemoradiotherapy or corticotherapy, immunosuppressive pathology)
- Allergy or intolerance to lactose, soy or yeast.
- Women under Coumadin
- Women who plan to give birth outside the participating center
- Women who do not plan to breastfeed or extract their milk in the first 10 days after delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the In-utero Transmission of Probiotics From the Mother to the Baby: A Randomized Crossover Pilot Study
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5 bacterial strains) compared to placebo.
Read the detailed description
Rational: Studies have shown that probiotics given to babies can reduce perinatal complications. A change of practice should therefore be introduced in the management of premature newborns. However, one could assume that probiotic administration before birth could be as effective if not more. Indeed, one could hypothesise that when the newborn is exposed to probiotics earlier, the protective effect is potentially increased.
Objective: This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby.
Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study Products under study: Probiotics containing 5 bacterial strains (total of 12 million colony-forming unit / day) vs. Placebo.
Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical, socio-demographic data) and will be randomized (double-blind) in one of the 2 following groups:
Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery.
Group B: taking placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery.
Follow-up: All women will complete a logbook to monitor the study products intake and monitor side effects until the end of the study (10 days postpartum).
Samples: maternal stool samples, vaginal secretions, stool (and meconium) as well as breast milk (and colostrum) will be taken at different times of the study to confirm the presence of probiotics and transmission between the mother and the baby.
- Conditions
- In Utero Drug Exposure
- Being tested
- Natural products: Probiotics, Placebo
- Keywords
- probiotic, in-utero transmission, pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural products: ProbioticsBiological
Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
PlaceboOther
Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
| Study group | Role | What they receive |
|---|---|---|
| prenatal probiotic | Active comparator | will take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery Receives: Biological: Natural products: Probiotics; Other: Placebo |
| postnatal probiotic | Active comparator | will take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery Receives: Biological: Natural products: Probiotics; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-utero transmission of probiotic
presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium
Measured: at birth
Secondary outcomes (5)
transmission of probiotic to colostrum
presence(yes or no) of probiotic (specific bacterial strains) in colostrum
Measured: at birth
transmission of probiotic to maternal milk
presence (yes or no) of probiotic (specific bacterial strains) in breastmilk
Measured: 10 days postpartum
transmission of probiotic to maternal vaginal tract
presence (yes or no) of probiotic (specific bacterial strains) in maternal vaginal swab
Measured: 37 weeks of gestation
transmission of probiotic to maternal gut
presence (yes or no) of probiotic (specific bacterial strains) in maternal stools
Measured: 37 weeks of gestation
postnatal transmission of probiotic to the neonate
presence (yes or no) of probiotic (specific bacterial strains) in neonate stools
Measured: 10 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start27 Apr 2022
- Primary completion28 Aug 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Utero Drug ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 2-arms randomized crossover pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Pasquier, MD, Principal investigator, CIUSSS-Estrie-CHUS hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050189
- Sponsor's protocol ID
- 2020-3242
- Acronym
- PROBIO
- Status last verified
- Dec 2023
- First submitted
- 5 Aug 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study. Samples and data will be used to confirm the principal hypothesis and explorative secondary objectives.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the In-utero Transmission of Probiotics From the Mother to the Baby: A Randomized Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT04050189
- Acronym / sponsor ID
- PROBIO / 2020-3242
- Conditions
- In Utero Drug Exposure
- Keywords
- probiotic, in-utero transmission, pilot study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5 bacterial strains) compared to placebo.
Detailed description
Rational: Studies have shown that probiotics given to babies can reduce perinatal complications. A change of practice should therefore be introduced in the management of premature newborns. However, one could assume that probiotic administration before birth could be as effective if not more. Indeed, one could hypothesise that when the newborn is exposed to probiotics earlier, the protective effect is potentially increased.
Objective: This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby.
Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study Products under study: Probiotics containing 5 bacterial strains (total of 12 million colony-forming unit / day) vs. Placebo.
Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical, socio-demographic data) and will be randomized (double-blind) in one of the 2 following groups:
Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery.
Group B: taking placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery.
Follow-up: All women will complete a logbook to monitor the study products intake and monitor side effects until the end of the study (10 days postpartum).
Samples: maternal stool samples, vaginal secretions, stool (and meconium) as well as breast milk (and colostrum) will be taken at different times of the study to confirm the presence of probiotics and transmission between the mother and the baby.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arms randomized crossover pilot study
| Arm | Type | Receives |
|---|---|---|
| prenatal probiotic | Active comparator | Biological: Natural products: Probiotics, Other: Placebowill take probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery |
| postnatal probiotic | Active comparator | Biological: Natural products: Probiotics, Other: Placebowill take placebo every day from the 34th week of pregnancy until delivery; taking probiotics for 10 days after delivery |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with a single pregnancy
- Women with a low risk pregnancy
- Women wishing to breastfeed at birth
- Women randomized between 32 0/7 - 33 6/7 weeks of gestation
Key exclusion criteria (11 listed)
- History of obstetric complications (prematurity <37 weeks, preeclampsia , gestational diabetes treated with insulin)
- Obstetric or fetal complications known for current pregnancy such as threaten preterm labor (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or anomalies, corticosteroid therapy
- Risk factors for obstetric complications during current pregnancy such as gestational diabetes, type I / II diabetes and high blood pressure (systole ≥140 and diastole ≥90)
- Antibiotic use within 2 weeks before randomisation
- Intake of probiotics or foods enriched with active cultures (fermented milk, kefir, kombucha ...) within 2 weeks before randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural products: ProbioticsProbiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum | Biological | postnatal probiotic, prenatal probiotic |
| PlaceboPlacebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum | Other | postnatal probiotic, prenatal probiotic |
Primary outcome
in-utero transmission of probiotic
Time frame: at birth
presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium
5 secondary outcomes
transmission of probiotic to colostrum
Time frame: at birth
transmission of probiotic to maternal milk
Time frame: 10 days postpartum
transmission of probiotic to maternal vaginal tract
Time frame: 37 weeks of gestation
transmission of probiotic to maternal gut
Time frame: 37 weeks of gestation
postnatal transmission of probiotic to the neonate
Time frame: 10 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No. This is a pilot study. Samples and data will be used to confirm the principal hypothesis and explorative secondary objectives.
Related trials for In Utero Drug Exposure
RecruitingObservational study
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
Pregnancy Related, Immune-mediated Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Pasquier, MD principal investigator
CIUSSS-Estrie-CHUS hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Natural products: Probiotics in people with In Utero Drug Exposure, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke 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 4 inclusion and 11 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 5 Dec 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. 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?
in-utero transmission of probiotic (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2023.