CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 173 enrolled
Drug / intervention
Lactobacillus plantarum strain 299 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03057054
NCT03057054Phase 3Active
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The Effectiveness of Lactobacillus Plantarum (LBP, IND# 17339) in Preventing Acute Graft-Versus-Host Disease (GvHD) in Children Undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Children's Oncology Group·interventional·Posted Feb 17, 2017·Updated Oct 6, 2025

In Brief

A Phase 3 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Lactobacillus plantarum strain 299, and 2 other interventions for Acute Graft Versus Host Disease and 3 related conditions. Active but no longer recruiting, targeting 173 participants across 43 sites in 2 countries.

Detailed Summary

This randomized phase III trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Leukemia, Lymphoma
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3ActiveOverdue
2017201820192020202120222023202420252026
First PostedFeb 17, 2017
Enrollment StartApr 30, 2018
Primary CompletionJun 30, 2022
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.4 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo alloHCT

Lactobacillus plantarum strain 299biological

Given PO or via NJ, NG or G tube

Lactobacillus plantarum strain 299vbiological

Given PO or via NJ, NG or G tube

Placebo Administrationother

Given PO or via NJ, NG or G tube