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Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

NCT03057054 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2025-10-06

Study results available
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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.

Conditions

  • Acute Graft Versus Host Disease
  • Hematopoietic and Lymphatic System Neoplasm
  • Leukemia
  • Lymphoma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHCT

BIOLOGICAL

Lactobacillus plantarum strain 299

Given PO or via NJ, NG or G tube

BIOLOGICAL

Lactobacillus plantarum strain 299v

Given PO or via NJ, NG or G tube

OTHER

Placebo Administration

Given PO or via NJ, NG or G tube

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Michael L Nieder · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2022-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03057054 on ClinicalTrials.gov