Vaginal Probiotics for Premature Rupture of Membranes

(PROB-PROM Trial)

Overseen By Sarah Bilodeau

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Vaginal probiotics, Oral probiotics

Disqualifiers: Active labor, Infection, Fetal distress, Weakened immune system, others

Compensation: Varies

Number of Visits: Unknown

Duration: From membrane rupture until delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether vaginal probiotics can help manage premature rupture of membranes (when the water breaks too early) in pregnant women. Researchers aim to determine if these probiotics are practical to use and if they can affect the microbiota (the community of bacteria) of preterm babies. Participants will use either a probiotic or a placebo (a pill that looks the same but has no active ingredients) until delivery and will track their symptoms and adherence to the treatment. Women pregnant with one baby who have experienced a premature rupture of membranes between 24 and 32 weeks may be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future pregnancies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking vaginal or oral probiotics, you must stop them 15 or 30 days before joining the study, respectively.

What prior data suggests that these vaginal probiotics are safe for use in cases of premature rupture of membranes?

Studies have shown that vaginal probiotics are generally well-tolerated by patients. Earlier research demonstrated that using vaginal probiotics helped reduce early water breaking and early births. This indicates the treatment is both effective and safe. No major reports of negative effects have emerged from using these probiotics during pregnancy and early water breaking. This makes them a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for premature rupture of membranes, which often involves antibiotics and corticosteroids to prevent infection and manage complications, vaginal probiotics offer a unique approach by introducing beneficial bacteria directly into the vaginal environment. Researchers are excited about this treatment because it leverages the body's natural microbiota to potentially reduce infection risk without relying on antibiotics, which can lead to resistance. This method aims to restore balance to the vaginal ecosystem, providing a non-invasive and natural option that could complement or even reduce the need for traditional treatments.

What evidence suggests that vaginal probiotics might be an effective treatment for premature rupture of membranes?

Research has shown that vaginal probiotics might help with early water breaking during pregnancy, known as premature rupture of membranes (PROM). This trial will compare a probiotics group with a placebo group to evaluate their effectiveness. Studies have found that these probiotics can lower the risk of PROM and early birth. In some cases, they also delay childbirth and lead to better health for the baby. When combined with antibiotics, probiotics can further improve outcomes around the time of birth. This suggests that probiotics play an important role in effectively managing PROM. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who experienced early water breaking (premature rupture of membranes) between 24-32 weeks of gestation. Participants will use a vaginal product and keep a diary on symptoms and adherence, as well as provide samples from themselves and their baby.

Inclusion Criteria

Mono-fetal pregnancy

I was treated for early water break between 24-32 weeks of pregnancy and was monitored without immediate delivery.

I can speak and read either French or English.

Exclusion Criteria

My unborn baby is showing signs of distress.

Allergy to soy or lactose

Vaginal probiotics intake 15 days before study inclusion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the vaginal study product from the time of membrane rupture until delivery and keep a diary documenting their symptoms and treatment adherence

From membrane rupture until delivery

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the collection of vaginal secretion samples and stool samples from their baby

From enrollment to infant 7th day of life

What Are the Treatments Tested in This Trial?

Interventions

• Vaginal Probiotics

Trial Overview The study tests the effects of vaginal probiotics versus placebo in managing pregnancies with premature rupture of membranes. It aims to see if this approach is feasible and how it affects the microbiota of preterm babies.

How Is the Trial Designed?

Group I: Probiotics group Active Control 1 Intervention

Probiotics is a mix of probiotic strains.

Group II: Placebo group Placebo Group 1 Intervention

Capsule of sugar, same appearance than the probiotic.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Lallemand Health Solutions, Canada

Collaborator

Trials

1

Recruited

80+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11644756/

Probiotics in the Prophylaxis of Premature Rupture of ... The results showed a significant reduction in the incidence of PROM and preterm birth in the probiotic group compared to the control group [17].

2. scientificarchives.com scientificarchives.com/article/the-effects-of-vaginal-probiotic-administration-on-perinatal-outcomes-in-patients-with-premature-preterm-rupture-of-membrane

The Effects of Vaginal Probiotic Administration on Perinatal ... The results of this study showed that the administration of vaginal probiotics in PPROM patients may be effective in delaying childbirth and reducing neonatal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211523007625

Vaginal probiotics as an adjunct to antibiotic prophylaxis in ... The combination of vaginal probiotics and antibiotic prophylaxis has been shown to effectively improve perinatal outcomes in women with PPROM.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06878443

Vaginal Probiotics During Pregnancy After Premature ... The goal of this clinical trial is to compare the microbiota of preterm babies born after premature breaking water with full-term babies microbiota.

5. tandfonline.com tandfonline.com/doi/abs/10.1080/01443615.2022.2151349

Vaginal probiotics on the outcomes of premature rupture of ... We studied the effects of vaginal probiotics (Lactobacillus rhamnosus and L. gasseri) on the outcomes of PROM in pregnant women between 24 and 36 weeks of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06965049

Vaginal Probiotics During Pregnancy After Premature (24- ... Premature rupture of fetal membranes before labor (PPROM) accounts for 30% of preterm births. Since PPROM is strongly associated with ascending vaginal ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1642942/full

Interaction of vaginal microbiota and biomarkers in ... This review synthesizes the relationship between vaginal microbiota and PROM risk, as well as microecology-targeted prevention and management strategies. A ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0882401025003985

The relationship between gut microbiota and preterm ... PPROM increases neonatal mortality risk, low birth weight, and maternal psychological impact. ... Gut dysbiosis disrupts intestinal barrier, allowing bacterial ...