PREvention of Preterm birth with Oral Probiotics

A randomised controlled trial investigating the impact of oral probiotic supplementation on the microbiome in pregnant women at high risk of preterm birth

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11963471

Enrollment

150

Registered

2021-03-31

Start date

2021-04-01

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women at high risk of preterm birth Pregnancy and Childbirth Preterm labor with preterm delivery

Interventions

Study randomisation will be conducted by a research statistician not involved in the trial. Using computer software, the statistician will generate three blocks of randomly allocated sequential study

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Previous preterm birth (<34 weeks gestation) 2. Previous second-trimester loss (14-24 weeks gestation) 3. =2 large loop excision of the transformation zone (LLETZ) procedures 4. =1 cone biopsy 5. Uterine anomaly

Exclusion criteria

Exclusion criteria: 1. Aged <18 years 2. Does not speak English and a suitable interpreter is unavailable 3. Cannot provide informed consent due to lack of understanding 4. Having a condition or taking medication, dietary supplement or food product that the investigators believe will interfere with the trial objectives

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 26/07/2023: Increase in the percentage of women with detectable Lactobacillus crispatus in the vaginal microbiome by 25% measured using shotgun metagenomic sequencing after at least twelve weeks of oral supplementation with commercial LBV product which contains Lactobacillus crispatus Previous primary outcome measure: 25% increase in the relative abundance of L. Crispatus measured using high-throughput DNA sequencing and/or qPCR after at least 12 weeks of oral supplementation	—

Measure

Time frame

Current primary outcome measure as of 26/07/2023: Increase in the percentage of women with detectable Lactobacillus crispatus in the vaginal microbiome by 25% measured using shotgun metagenomic sequencing after at least twelve weeks of oral supplementation with commercial LBV product which contains Lactobacillus crispatus Previous primary outcome measure: 25% increase in the relative abundance of L. Crispatus measured using high-throughput DNA sequencing and/or qPCR after at least 12 weeks of oral supplementation

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Secondary

Measure	Time frame
Current secondary outcome measure as of 26/07/2023: 1. Cervical length at 24 weeks gestation measured using transvaginal ultrasound after at least 12 weeks of oral supplementation 2. Compliance with the intervention measured by counting remaining capsules at 1 month postpartum 3. Preterm premature rupture of membranes measured from patient notes at the time of birth 4. Histological chorioamnionitis measured using placental histopathology at the time of birth 5. Gestational age at delivery measured from patient notes at the time of birth 6. NICU admissions measured from patient notes at 1 month postpartum 7. Neonatal complications measured from patient notes at 1 month postpartum Previous secondary outcome measure: 1. Cervical length at 26-34 weeks gestation measured using transvaginal ultrasound after at least 12 weeks of oral supplementation 2. Compliance with the intervention measured by counting remaining capsules at 1 month postpartum 3. Preterm premature rupture of membranes measured from patient notes at the time of birth 4. Histological chorioamnionitis measured using placental histopathology at the time of birth 5. Gestational age at delivery measured from patient notes at the time of birth 6. NICU admissions measured from patient notes at 1 month postpartum 7. Neonatal complications measured from patient notes at 1 month postpartum	—

Measure

Time frame

Current secondary outcome measure as of 26/07/2023: 1. Cervical length at 24 weeks gestation measured using transvaginal ultrasound after at least 12 weeks of oral supplementation 2. Compliance with the intervention measured by counting remaining capsules at 1 month postpartum 3. Preterm premature rupture of membranes measured from patient notes at the time of birth 4. Histological chorioamnionitis measured using placental histopathology at the time of birth 5. Gestational age at delivery measured from patient notes at the time of birth 6. NICU admissions measured from patient notes at 1 month postpartum 7. Neonatal complications measured from patient notes at 1 month postpartum Previous secondary outcome measure: 1. Cervical length at 26-34 weeks gestation measured using transvaginal ultrasound after at least 12 weeks of oral supplementation 2. Compliance with the intervention measured by counting remaining capsules at 1 month postpartum 3. Preterm premature rupture of membranes measured from patient notes at the time of birth 4. Histological chorioamnionitis measured using placental histopathology at the time of birth 5. Gestational age at delivery measured from patient notes at the time of birth 6. NICU admissions measured from patient notes at 1 month postpartum 7. Neonatal complications measured from patient notes at 1 month postpartum

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Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026