PregnancyPROBPROM-PilotNCT06878443
Vaginal Probiotics During Pregnancy After Premature Rupture of Membranes
A study testing Vaginal probiotics 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 compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota. The main questions it aims to answer are: Is babies' microbiota differs with premature water breaking than full-term babies microbiota? Is vaginal probiotics given to the… 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?
- Vaginal probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2025to 17 Jun 2025
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Groups A and B:
- Women ≥ 18 years of age, mono-fetal pregnancy, hospitalized for PPROM between 32 0/7 d and 36 0/7 d weeks of ammenorhea with LP \< 7 days in one of the participating centers, with expectant management, who have consented to participate, agree to collect samples and speak French or English
- Group C:
- Women ≥ 18 years, mono-fetal pregnancy, expected delivery in one of the participating centers and speaking French or English
Who cannot join
- Groups A and B:
- Presence of active labor,
- Situations contraindicating expectant management (e.g. infection),
- Significant malformation, chromosomal abnormality or fetal death,
- Signs of fetal distress,
- vaginal probiotics intake 15 days before study entry.
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- For Group A only:
- Allergies to soy and/or milk;
- Weakened immune system (e.g. AIDS, prolonged treatment with corticosteroids),
- Not to have been treated with the following antibiotics during pregnancy: nalidixic acid (Negram) and/or cefoxitin (Mefoxin) and/or sulfamethoxazole (Bactrim).
- Group C:
- History of obstetric complications (prematurity \<37 weeks, diagnosed pre-eclampsia, gestational diabetes treated with insulin),
- Known obstetrical or fetal complications of the current pregnancy, such as threat of preterm delivery (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or malformation, corticosteroid therapy,
- Risk factors for obstetrical complications during pregnancy, such as gestational diabetes, type I/II diabetes and high blood pressure (systole ≥ 140 and diastole ≥ 90),
- Antibiotics taken 15 days prior to inclusion,
- Taking probiotics 15 days prior to inclusion,
- Tested positive for Streptococcus group B during previous pregnancies (as this will require antibiotics at delivery),
- Presence of symptoms such as fever, nausea, vomiting, bloody diarrhea or severe abdominal pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Clinical Pilot Essay Testing Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 32 and 36 Weeks of Amenorrhea ( PROBPROM-Pilot Study)
The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.
The main questions it aims to answer are:
Read more
- Is babies' microbiota differs with premature water breaking than full-term babies microbiota?
- Is vaginal probiotics given to the mother influence the baby microbiota? Researchers will compare vaginal probiotics use to no treatment to see if the babies microbiota and mother microbiota is influenced.
Participants will
- Take vaginal probiotics between premature breaking water until delivery (group A)
- Keep a diary of their symptoms and compliance to treatment (group A)
- Take samples of vaginal secretions and of baby's stool (all groups)
Read the detailed description
Premature rupture of fetal membranes before labor (PPROM) reprensents 30% of premature births. As PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). They prolong the LP and improve the health of the children, but they also aggravate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) stabilizes the vaginal microbiota (VM) and increases Lactobacillus levels. By increasing the number of good germs in the vagina, they will rebalance the good germs and the pathogenic germs that make their way up to the uterus. This could reduce uterine infection and improve the foetus; intestinal flora.
Pathophysiological hypotheses for improving neonatal health:
The use of VP could have three modes of action on neonatal outcome:
- decrease vaginal dysbiosis: pregnancy prolongation and reduce fetal immaturity complications (e.g.reduce intraventricular hemorrhage); ii) Reduction of intra-uterine infection/inflammation: Reduce neonatal complications linked to inflammation (e.g. diminish cystic periventricular leukomalacia); iii) improvement of neonatal intestinal microbiota (NIM) (probiotic swallowing): reduce complications associated with neonatal dysbiosis (e.g. reduce ulcerative colitis (NEC)).
3.1 Primary objective Mechanistic proof of concept To compare the NIM of the babies of the participants after PPROM with or without probiotics compared with the NIM of the babies of the participants without PRPOM (meconium and at 7 days of life).
Secondary objectives Primary secondary objectives (Group A or B versus C)
- To compare the VM of participants after PPROM with or without probiotics with the VM of participants without PPROM at the end of pregnancy (early latency phase).
- Compare the VM of participants after PPROM with or without probiotics with the VM of participants without PPROM in early labor (end of latency phase).
- To test the possibility of transmission analysis of VP in the NIM (meconium and at 7 d of life) with groups B and C: PPROM-control and control without PPROM.
Secondary clinical objectives
- Explore recruitment (rate, reasons for acceptance and refusal, characteristics of mothers recruited), treatment adherence \>80% and attrition rate \<5%.
- Test tools for sample collection, participant information and consent form.
Population:
Pregnant women aged 18 and over, giving birth at one the three centers participating in the study CHUM, CHUSJ or CHUQ (Quebec). These women will be divided into 3 groups:
- Group A: PPROM-VP Pregnant women admitted for PPROM with VP intake
- Group B: PPROM-control Pregnant women admitted for PPROM without VP intake
- Group C: term-control without PPROM Pregnant women with expected full-term deliveries, without VP intake
- Conditions
- Pregnancy, Prematurity, PPROM
- Being tested
- Vaginal probiotics
- 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.
Vaginal probioticsOther
Probiotics from Canadian company Lallemand Health Solutions are stored at room temperature and administered vaginally.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Pregnant women admitted to one of the center participating in the essay for PPROM accepting vaginal probiotics intake and sample collection Receives: Other: Vaginal probiotics |
| Control group - PPROM | No intervention | Pregnant women admitted to one of the study's centers for PPROM without vaginal probiotics intake |
| Control group- Full Term | No intervention | Pregnant women with expected full-term deliveries, without vaginal probiotics intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotics primers presence
Evaluate the presence or absence of probiotics in the meconium and stools of 7-day-old babies using specific primers to detect strains
Measured: at birth and 7th day of life
Secondary outcomes (5)
Recruitment rate
To assess feasability of the study the recruitment will be explored (recruitment rate = (# of eligible patient- # of patient who didn't consent) / # of eligible patient), also, reasons for acceptance and refusal, characteristics of mothers recruited will be documented.
Measured: 12 months
Numbers of mother and baby health issues
Monitor side-effects reported in the logbook and medical record, as well as clinical outcomes for mother and baby
Measured: During the enrollment until 30 days after delivery
Probiotics primers in other samples presence
Evaluate the presence or absence of probiotics in the various samples, i.e. vaginal secretions, meconium and 7-day-old baby's stools, using specific primers to detect strains, and ii) perform microbiota analysis to compare the microbiota of mothers with and without PPROM.
Measured: between the enrollment until 30 days after delivery
Attrition rate
To assess feasability of the study, the attrition rate will be explored. Attrititon rate = (# participants who dropped out / total of participants)
Measured: 13 months
Treatment adherence
# of caps took during the treatment phase will be reported to explore the adherence of treatment. This will help to assess feasability of the study
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start17 Jun 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Why it stopped: Important delays limiting study starts
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Vaginal Probiotics 1x/day until delivery
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878443
- Sponsor's protocol ID
- MP-02-2025-12298
- Acronym
- PROBPROM-Pilot
- Status last verified
- Jul 2025
- First submitted
- 10 Sep 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Pilot Essay Testing Association Between Antibiotics and Vaginal Probiotics for Patients With Prematured Rupture of Membranes Between 32 and 36 Weeks of Amenorrhea ( PROBPROM-Pilot Study)
- ClinicalTrials.gov ID
- NCT06878443
- Acronym / sponsor ID
- PROBPROM-Pilot / MP-02-2025-12298
- Conditions
- Pregnancy, Prematurity, PPROM
- Keywords
- pregnancy, prematurity, PPROM, vaginal probiotics, microbiota
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Important delays limiting study starts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 17 Mar 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 compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.
The main questions it aims to answer are:
- Is babies' microbiota differs with premature water breaking than full-term babies microbiota?
- Is vaginal probiotics given to the mother influence the baby microbiota? Researchers will compare vaginal probiotics use to no treatment to see if the babies microbiota and mother microbiota is influenced.
Participants will
- Take vaginal probiotics between premature breaking water until delivery (group A)
- Keep a diary of their symptoms and compliance to treatment (group A)
- Take samples of vaginal secretions and of baby's stool (all groups)
Detailed description
Premature rupture of fetal membranes before labor (PPROM) reprensents 30% of premature births. As PPROM is strongly associated with ascending vaginal infection, antibiotics are recommended during the latent period (LP) (the interval between rupture and birth). They prolong the LP and improve the health of the children, but they also aggravate pre-existing vaginal dysbiosis. The addition of vaginal probiotics (VP) stabilizes the vaginal microbiota (VM) and increases Lactobacillus levels. By increasing the number of good germs in the vagina, they will rebalance the good germs and the pathogenic germs that make their way up to the uterus. This could reduce uterine infection and improve the foetus; intestinal flora.
Pathophysiological hypotheses for improving neonatal health:
The use of VP could have three modes of action on neonatal outcome:
- decrease vaginal dysbiosis: pregnancy prolongation and reduce fetal immaturity complications (e.g.reduce intraventricular hemorrhage); ii) Reduction of intra-uterine infection/inflammation: Reduce neonatal complications linked to inflammation (e.g. diminish cystic periventricular leukomalacia); iii) improvement of neonatal intestinal microbiota (NIM) (probiotic swallowing): reduce complications associated with neonatal dysbiosis (e.g. reduce ulcerative colitis (NEC)).
3.1 Primary objective Mechanistic proof of concept To compare the NIM of the babies of the participants after PPROM with or without probiotics compared with the NIM of the babies of the participants without PRPOM (meconium and at 7 days of life).
Secondary objectives Primary secondary objectives (Group A or B versus C)
- To compare the VM of participants after PPROM with or without probiotics with the VM of participants without PPROM at the end of pregnancy (early latency phase).
- Compare the VM of participants after PPROM with or without probiotics with the VM of participants without PPROM in early labor (end of latency phase).
- To test the possibility of transmission analysis of VP in the NIM (meconium and at 7 d of life) with groups B and C: PPROM-control and control without PPROM.
Secondary clinical objectives
- Explore recruitment (rate, reasons for acceptance and refusal, characteristics of mothers recruited), treatment adherence \>80% and attrition rate \<5%.
- Test tools for sample collection, participant information and consent form.
Population:
Pregnant women aged 18 and over, giving birth at one the three centers participating in the study CHUM, CHUSJ or CHUQ (Quebec). These women will be divided into 3 groups:
- Group A: PPROM-VP Pregnant women admitted for PPROM with VP intake
- Group B: PPROM-control Pregnant women admitted for PPROM without VP intake
- Group C: term-control without PPROM Pregnant women with expected full-term deliveries, without VP intake
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Vaginal Probiotics 1x/day until delivery
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Other: Vaginal probioticsPregnant women admitted to one of the center participating in the essay for PPROM accepting vaginal probiotics intake and sample collection |
| Control group - PPROM | No intervention | –Pregnant women admitted to one of the study's centers for PPROM without vaginal probiotics intake |
| Control group- Full Term | No intervention | –Pregnant women with expected full-term deliveries, without vaginal probiotics intake |
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)
- Groups A and B:
- Women ≥ 18 years of age, mono-fetal pregnancy, hospitalized for PPROM between 32 0/7 d and 36 0/7 d weeks of ammenorhea with LP \< 7 days in one of the participating centers, with expectant management, who have consented to participate, agree to collect samples and speak French or English
- Women ≥ 18 years, mono-fetal pregnancy, expected delivery in one of the participating centers and speaking French or English
Key exclusion criteria (18 listed)
- Groups A and B:
- Presence of active labor,
- Situations contraindicating expectant management (e.g. infection),
- Significant malformation, chromosomal abnormality or fetal death,
- Signs of fetal distress,
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 |
|---|---|---|
| Vaginal probioticsProbiotics from Canadian company Lallemand Health Solutions are stored at room temperature and administered vaginally. | Other | Probiotics group |
Primary outcome
Probiotics primers presence
Time frame: at birth and 7th day of life
Evaluate the presence or absence of probiotics in the meconium and stools of 7-day-old babies using specific primers to detect strains
5 secondary outcomes
Recruitment rate
Time frame: 12 months
Numbers of mother and baby health issues
Time frame: During the enrollment until 30 days after delivery
Probiotics primers in other samples presence
Time frame: between the enrollment until 30 days after delivery
Attrition rate
Time frame: 13 months
Treatment adherence
Time frame: 13 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal probiotics 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 18 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: withdrawn, as of the sponsor's last update on 4 Jul 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Probiotics primers presence (time frame: at birth and 7th day of life). 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 4 Jul 2025.