MedTrace Logo

STP206 for the Prevention of Necrotizing Enterocolitis (NEC)

NCT01954017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-03-24

Study results available
· View outcomes & findings →

Summary

This study is a sequential dose escalation study to assess the safety, tolerability, and preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth weight and extremely low birth weight neonates.

Conditions

  • Necrotizing Enterocolitis

Interventions

BIOLOGICAL

STP206

Live Biotherapeutic

OTHER

Control

Sterile Water

Sponsors & Collaborators

  • Leadiant Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael S Caplan, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-30
Primary Completion
2018-02-28
Completion
2018-10-22

Countries

  • United States

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 NCT01954017 on ClinicalTrials.gov