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SEPSIS: L. Plantarum Trial

NCT05180201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 519

Last updated 2023-04-13

No results posted yet for this study

Summary

Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited settings. The goal of the Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS) phase II L. plantarum trial is to generate knowledge on the safety, tolerability and effects on the microbiome of Lactiplantibacillus plantarum, with or without fructooligosaccharide, in infants (birth to 60 days of age) in Dhaka, Bangladesh. All data generated will support the design and implementation of a phase III trial to test the efficacy of the probiotic/synbiotic or other interventions for the prevention of SI, promotion of optimal growth and development, and effects on other health outcomes in early infancy.

Conditions

  • Microbial Colonization
  • Tolerance
  • Safety Issues
  • Infant ALL

Interventions

DIETARY_SUPPLEMENT

Synbiotic

Lactiplantibacillus plantarum ATCC 202195 with fructooligosaccharide

DIETARY_SUPPLEMENT

Probiotic

Lactiplantibacillus plantarum ATCC 202195

OTHER

Placebo

Maltodextrin

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Child Health Research Foundation, Bangladesh

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Daniel Roth, MD, PhD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-06-21
Completion
2022-11-10

Countries

  • Bangladesh

Study Locations

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Entities

Companies

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 NCT05180201 on ClinicalTrials.gov