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Completed

NCT Number: NCT06231056

Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection

Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology PERUGIA HOSPITAL

Perugia, 06122, Italy

About this study

There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.

Recent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.

The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.

This was a retrospective, observational, controlled and single centre study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women in 24-36 weeks of gestation period
  • History of recurrent genitourinary and/or intestinal problems

Exclusion criteria

  • Presence of neurological condition
  • History of cardiovascular disease
  • History of pulmonary disease
  • History of renal disease
  • Cancer

Treatment and study plan

Probiotic iNatal®

Dietary Supplement

iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215)

Primary outcomes

  1. Bacteriological assessment

    Time frame: 12 weeks

    Control of bacteriuria by urine culture (number of participants)

  2. Bacteriological assessment

    Time frame: 12 weeks

    Incidencce of Group B β-hemolytic streptococcus (GBS) infection positivity investigation by vaginal and/or rectal swab

  3. Clinical assessments at the end of pregnancy

    Time frame: 12 weeks

    Incidence of Prelabor rupture of membranes (PROM)

  4. Clinical assessments at the end of pregnancy

    Time frame: 12 weeks

    Incidence of Preterm PROM (PPROM)

  5. Clinical assessments at the end of pregnancy

    Time frame: 12 weeks

    Incidence of Preterm birth

  6. clinical assessments at the end of pregnancy

    Time frame: 12 weeks

    Rate of natural or caesarean section mode

  7. Clinical assessments at the end of pregnancy

    Time frame: 12 weeks

    Incidence of induction of child birth

Secondary outcomes

  1. Rate of incidence of side effects

    Time frame: 12 weeks

    Number of participants presenting any side effects

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • Università degli Studi dell'Insubria

Registry information

Official study title

Probiotic Therapy in Pregnancy for the Reduction of Streptococcus Agalactiae Positivity and the Frequency of PROM, pPROM and Preterm Birth

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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