MedTrace Logo

Use of Probiotics to Reduce Infections, Death and ESBL Colonisation

NCT04172012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-04-25

No results posted yet for this study

Summary

This study examines the effect of oral probiotic treatment to newborns on preventing hospitalizations, death and colonization with Extended-spectrum beta-lactamase-producing Gram negative bacteria. Half of the babies will receive 4 weeks treatment with an oral mixture of the probiotic Labinic (R) while the other half will receive a placebo mixture.

Conditions

  • Neonatal Sepsis

Interventions

BIOLOGICAL

Labinic (R) probiotic mixture

Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve

OTHER

Placebo

Placebo mixture

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Helse Stavanger HF

    collaborator OTHER_GOV

  • UiT The Arctic University of Norway

    collaborator OTHER

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Haydom Lutheran Hospital

    lead OTHER

Principal Investigators

  • Nina Langeland, MD, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-07-10
Completion
2023-09-19

Countries

  • Tanzania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04172012 on ClinicalTrials.gov