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

NCT06231056 | Completed DMC

• 1 other identifier: LUMHS/iNatal/20.01.2024
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genitourinary; Infection, Complicating Pregnancy

Outcome Measures

Primary Outcomes (7)

• Bacteriological assessment

  Control of bacteriuria by urine culture (number of participants)

  12 weeks

• Bacteriological assessment

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

  12 weeks

• Clinical assessments at the end of pregnancy

  Incidence of Prelabor rupture of membranes (PROM)

  12 weeks

• Clinical assessments at the end of pregnancy

  Incidence of Preterm PROM (PPROM)

  12 weeks

• Clinical assessments at the end of pregnancy

  Incidence of Preterm birth

  12 weeks

• clinical assessments at the end of pregnancy

  Rate of natural or caesarean section mode

  12 weeks

• Clinical assessments at the end of pregnancy

  Incidence of induction of child birth

  12 weeks

Secondary Outcomes (1)

• Rate of incidence of side effects

  12 weeks

Study Arms (2)

Probiotic supplement group

EXPERIMENTAL

Participants in this group received probiotic iNatal® (Enterococcus faecium L3, Bifidobacterium animalis subsp. lactis BB-12, Lactococcus lactis SP38, Lacticaseibacillus casei R0215) - dosage 1 sachet per day, during the 24-36 weeks of their gestation period.

Dietary Supplement: Probiotic iNatal®

Control group

NO INTERVENTION

No probiotic supplementation. Participants in this group did not received probiotic iNatal® during 24-36 weeks of their gestation period.

Interventions

Probiotic iNatal® DIETARY_SUPPLEMENT

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

Probiotic supplement group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study is only applicable in pregnant female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology PERUGIA HOSPITAL

Perugia, 06122, Italy

Location

MeSH Terms

Conditions

Infections; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Control group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Probiotic supplement group

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 30, 2024
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)