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Preterm-birth-prevention with Lactobacillus crispatus oral probiotics: Protocol for a double blinded randomised
Gillian A Corbett1, Siobhan Corcoran1, Conor Feehily2
1UCD Perinatal Research Centre, UCD School of Medicine, University College Dublin, National Maternity Hospital, Dublin 2, Ireland; National Maternity Hospital, Dublin 2, Ireland.
Insights
This study investigates an oral probiotic containing Lactobacillus crispatus to prevent spontaneous preterm birth (sPTB). The aim is to increase L. crispatus in the vaginal microbiome, potentially reducing sPTB risk in high-risk pregnancies.
Area of Science:
- Microbiology
- Obstetrics
- Genetics
Background:
- Spontaneous preterm birth (sPTB) prevention remains a clinical challenge.
- Reduced vaginal Lactobacillus crispatus is associated with sPTB.
- This study addresses the need for effective sPTB prevention strategies.
Purpose of the Study:
- To evaluate the impact of an oral probiotic containing L. crispatus on the maternal vaginal and gut microbiome.
- To assess the efficacy of L. crispatus supplementation in pregnancies at high risk for sPTB.
- To investigate the direct and indirect effects of the probiotic on vaginal and gut microbial composition.
Main Methods:
- A double-blind, placebo-controlled, randomized trial involving 126 women at high risk for sPTB.
- Participants received oral supplementation with a probiotic (containing L. crispatus, L. rhamnosus, L. jensenii, L. gasseri) or placebo for twelve weeks.
- Vaginal and gut microbiome analysis using high-throughput DNA sequencing, alongside assessment of secondary outcomes like sPTB rates and neonatal outcomes.
Main Results:
- The primary outcome is the detection of L. crispatus in the vaginal microbiome after twelve weeks of probiotic treatment.
- A 25% increase in detectable L. crispatus is the target for statistical significance.
- Secondary outcomes will assess the intervention's effects on the gut microbiome, metabolome, and clinical pregnancy outcomes.
Conclusions:
- This randomized trial will determine if an oral probiotic containing L. crispatus can successfully increase its vaginal abundance.
- The study will explore the probiotic's influence on the gut microbiome and metabolome.
- Findings may offer a novel strategy for preventing spontaneous preterm birth.
Introduction:
Effective spontaneous preterm birth (sPTB) prevention is an urgent unmet clinical need. Vaginal depletion of Lactobacillus crispatus is linked to sPTB. This trial will investigate impact of an oral Lactobacillus spp. probiotic product containing an L. crispatus strain with other Lactobacilli spp., on the maternal vaginal and gut microbiome in pregnancies high-risk for sPTB.
Methods:
A double-blind, placebo-controlled, randomised trial will be performed at the National Maternity Hospital Dublin, Ireland. Inclusion criteria are women with history of sPTB or mid-trimester loss, cervical surgery (cone biopsy or two previous large-loop-excision-of-transformation-zone) or uterine anomaly. The intervention is oral supplementation for twelve weeks with probiotic or identical placebo. The probiotic will contains: ◦ 4 billion CFU Lactobacillus crispatus Lbv 88(2x109CFU/Capsule) ◦ 4 billion CFU Lactobacillus rhamnosus Lbv 96(2x109CFU/Capsule) ◦ 0.8 billion CFU Lactobacillus jensenii Lbv 116(0.4x109CFU/Capsule) ◦ 1.2 billion CFU Lactobacillus gasseri Lbv 150(0.6x109CFU/Capsule). Investigators and participants will be blinded to assignment.
Results:
The primary outcome is detectable L. crispatus in the vaginal microbiome after twelve weeks of treatment, measured using high-throughput DNA sequencing. A total of 126 women are required to detect a 25 % increase in detectable L. crispatus. Secondary outcomes include impact of intervention on the gut microbiome and metabolome, rate of sPTB and mid-trimester loss, neonatal outcomes and maternal morbidity.
Conclusions:
This randomised trial will investigate ability of an oral probiotic containing L. crispatus to increase its abundance in the vaginal microbiome, both directly by horizontal transfer and indirectly via microbiome and metabolome of the gut.
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