PregnancyPROB-PROMNCT06965049
Vaginal Probiotics During Pregnancy After Premature (24-32 Weeks of Gestation) Preterm Rupture of Membranes
A study testing Probiotic in people with Pregnancy and Prematurity, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT). Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Prematurity, PPROM
- 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
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women ≥ 18 years of age;
- mono-fetal pregnancy;
- treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and < 7 days in one of the study centers with expectant management;
- speaking and able to read French or English.
Who cannot join
- Presence of active labor;
- Situation contraindicating expectant management (e.g., infection);
- Significant malformation, chromosomal anomaly, or fetal death;
- Signs of fetal distress;
- Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;
- Allergy to soy or lactose;
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- Weakened immune system (e.g., AIDS, prolonged corticosteroid treatment, etc.);
- Vaginal probiotics intake 15 days before study inclusion;
- Oral probiotic intake 30 days before study inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre de recherche du CHUM
Montreal, Quebec, H2X 0A9
Sarah Bilodeau, 514-890-8000 ext. 30620, sarah.bilodeau.chum@ssss.gouv.qc.ca
Bilodeau
About this study
Official title: Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).
Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.
To achieve this, participants will be asked to:
- Use the vaginal study product from the time of membrane rupture until delivery
- Keep a diary documenting their symptoms and treatment adherence
- Provide vaginal secretion samples and stool samples from their baby
Read the detailed description
Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). While they prolong the LP and improve neonatal health, they also exacerbate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) helps stabilize the vaginal microbiota (VM) and increase Lactobacillus levels. By enhancing the presence of beneficial bacteria in the vagina, probiotics help restore the balance between beneficial and pathogenic microbes, potentially reducing uterine infection and improving the fetal intestinal microbiota.
Pathophysiological Hypotheses for Improving Neonatal Health
The use of VP may influence neonatal outcomes through three potential mechanisms:
- Reduction of vaginal dysbiosis: Prolongs pregnancy and mitigates complications related to fetal immaturity (e.g., decreases risk of intraventricular hemorrhage). ii) Reduction of intrauterine infection/inflammation: Lowers neonatal complications associated with inflammation (e.g., reduces incidence of cystic periventricular leukomalacia). iii) Improvement of neonatal intestinal microbiota (NIM) through probiotic ingestion: Decreases complications linked to neonatal dysbiosis (e.g., reduces risk of necrotizing enterocolitis [NEC]).
Primary Objectives
- To assess the validity of:
- A recruitment rate > 35% ii) A treatment adherence rate > 80% iii) A sample attrition rate < 5%
- To identify barriers and facilitators in different settings for the implementation of the randomized controlled trial (RCT).
Secondary Objectives
- To compare the presence of probiotics in the vaginal microbiota and neonatal stool (meconium and at 7 days of life).
- To measure the effect of probiotics on the evolution of maternal vaginal microbiota and neonatal intestinal microbiota.
Population Pregnant women aged 18 years or older giving birth at one of the eight centers participating in the study in Quebec and Ontario, Canada. Participants will be randomly assigned, in a blinded manner, to either the probiotic or placebo group.
- Conditions
- Pregnancy, Prematurity, PPROM
- Being tested
- Probiotic, Placebo
- Keywords
- pregnancy, prematurity, PPROM, vaginal probiotics, microbiota
- Medical subject headings
- Premature Birth, Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
PlaceboOther
Participant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Active comparator | Probiotics is a mix of probiotic strains. Receives: Other: Probiotic |
| Placebo group | Placebo comparator | Capsule of sugar, same appearance than the probiotic. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To assess the feasibility of the study, each local site team will complete a dashboard documenting every individual met and informed about the study. This dashboard will be used to calculate the recruitment rate, using the formula:
Recruitment rate = (Number of eligible patients - Number of patients who did not consent) / Number of eligible patients Additionally, the dashboard will track reasons for acceptance or refusal.
Measured: 7 months
Feasability dashboard
The attrition rate will be explored to assess feasability of the study. Attrititon rate = (# participants who dropped out / total of participants).
Measured: 7 months
Treatment adherence
Finally, number of caps took during the treatment phase will be reported to explore the adherence of treatment.
Measured: 7 months
Secondary outcomes (1)
Probiotics primers
Evaluate the presence or absence of probiotics in the various samples, i.e. vaginal secretions, meconium and 7-day-old baby's stool, using specific primers to detect strains.
Measured: From enrollement to infant 7th day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965049
- Sponsor's protocol ID
- MP-02-2025-12882
- Acronym
- PROB-PROM
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP) and informed Consent Form (ICF). No data concerning individual participant will be shared or published.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Pilot Trial Testing the Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 24 and 32 Weeks of Amenorrhea ( PROB-PROM Study)
- ClinicalTrials.gov ID
- NCT06965049
- Acronym / sponsor ID
- PROB-PROM / MP-02-2025-12882
- Conditions
- Pregnancy, Prematurity, PPROM
- Keywords
- pregnancy, prematurity, PPROM, vaginal probiotics, microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Lallemand Health Solutions, Canada
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 May 2025 (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.
The goal of this clinical trial is to evaluate the feasibility of the randomized controlled trial (RCT).
Secondary objectives include comparing the microbiota of preterm babies born after premature rupture of membranes across study groups.
To achieve this, participants will be asked to:
- Use the vaginal study product from the time of membrane rupture until delivery
- Keep a diary documenting their symptoms and treatment adherence
- Provide vaginal secretion samples and stool samples from their baby
Detailed description
Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). While they prolong the LP and improve neonatal health, they also exacerbate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) helps stabilize the vaginal microbiota (VM) and increase Lactobacillus levels. By enhancing the presence of beneficial bacteria in the vagina, probiotics help restore the balance between beneficial and pathogenic microbes, potentially reducing uterine infection and improving the fetal intestinal microbiota.
Pathophysiological Hypotheses for Improving Neonatal Health
The use of VP may influence neonatal outcomes through three potential mechanisms:
- Reduction of vaginal dysbiosis: Prolongs pregnancy and mitigates complications related to fetal immaturity (e.g., decreases risk of intraventricular hemorrhage). ii) Reduction of intrauterine infection/inflammation: Lowers neonatal complications associated with inflammation (e.g., reduces incidence of cystic periventricular leukomalacia). iii) Improvement of neonatal intestinal microbiota (NIM) through probiotic ingestion: Decreases complications linked to neonatal dysbiosis (e.g., reduces risk of necrotizing enterocolitis [NEC]).
Primary Objectives
- To assess the validity of:
- A recruitment rate > 35% ii) A treatment adherence rate > 80% iii) A sample attrition rate < 5%
- To identify barriers and facilitators in different settings for the implementation of the randomized controlled trial (RCT).
Secondary Objectives
- To compare the presence of probiotics in the vaginal microbiota and neonatal stool (meconium and at 7 days of life).
- To measure the effect of probiotics on the evolution of maternal vaginal microbiota and neonatal intestinal microbiota.
Population Pregnant women aged 18 years or older giving birth at one of the eight centers participating in the study in Quebec and Ontario, Canada. Participants will be randomly assigned, in a blinded manner, to either the probiotic or placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Active comparator | Other: ProbioticProbiotics is a mix of probiotic strains. |
| Placebo group | Placebo comparator | Other: PlaceboCapsule of sugar, same appearance than the probiotic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women ≥ 18 years of age;
- mono-fetal pregnancy;
- treated for PPROM between 24 and 32 weeks of gestation with latency period between 12 hours and < 7 days in one of the study centers with expectant management;
- speaking and able to read French or English.
Key exclusion criteria (9 listed)
- Presence of active labor;
- Situation contraindicating expectant management (e.g., infection);
- Significant malformation, chromosomal anomaly, or fetal death;
- Signs of fetal distress;
- Allergy or intolerance to any of the following substances: vitamin C (ascorbic acid), magnesium stearate, maltodextrin, gelatin, yeast, sucrose, trehalose;
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 |
|---|---|---|
| ProbioticParticipant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery | Other | Probiotics group |
| PlaceboParticipant will take 1 intravaginal capsule once a day at bedtime between inclusion in the study until delivery | Other | Placebo group |
Primary outcome
Recruitment rate
Time frame: 7 months
To assess the feasibility of the study, each local site team will complete a dashboard documenting every individual met and informed about the study. This dashboard will be used to calculate the recruitment rate, using the formula: Recruitment rate = (Number of eligible patients - Number of patients who did not consent) / Number of eligible patients Additionally, the dashboard will track reasons for acceptance or refusal.
Feasability dashboard
Time frame: 7 months
The attrition rate will be explored to assess feasability of the study. Attrititon rate = (# participants who dropped out / total of participants).
Treatment adherence
Time frame: 7 months
Finally, number of caps took during the treatment phase will be reported to explore the adherence of treatment.
1 secondary outcome
Probiotics primers
Time frame: From enrollement to infant 7th day of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP) and informed Consent Form (ICF). No data concerning individual participant will be shared or published.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Pregnancy and Prematurity, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 9 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: opening soon, as of the sponsor's last update on 11 May 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Charles Pasquier (819-679-2212, jean-charles.pasquier@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 7 months). The study lists 3 primary outcomes in all. 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 11 May 2025.