Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 3

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

NCT03057054 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • OTHER Placebo Administration
  • BIOLOGICAL Lactobacillus plantarum strain 299
  • BIOLOGICAL Lactobacillus plantarum strain 299v

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • Children's Hospital Los Angeles — Los Angeles
  • UCSF Benioff Children's Hospital Oakland — Oakland
  • Rady Children's Hospital - San Diego — San Diego
  • UCSF Medical Center-Mission Bay — San Francisco

Florida

  • University of Florida Health Science Center - Gainesville — Gainesville
  • Nemours Children's Clinic-Jacksonville — Jacksonville
  • Nemours Children's Hospital — Orlando
  • Johns Hopkins All Children's Hospital — St. Petersburg

Alabama

  • Children's Hospital of Alabama — Birmingham

Colorado

  • Children's Hospital Colorado — Aurora

Connecticut

  • Yale University — New Haven

Delaware

  • Alfred I duPont Hospital for Children — Wilmington

District of Columbia

  • Children's National Medical Center — Washington D.C.

Hawaii

  • Kapiolani Medical Center for Women and Children — Honolulu

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2018-04-30
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Children's Oncology Group

318 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03057054

The ClinicalTrials.gov registry entry for NCT03057054 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions — of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03057054 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03057054 about?

NCT03057054 is a clinical study titled "Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant". 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, adolesce...

What is the current status of trial NCT03057054?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2018-04-30. Estimated completion is 2026-06-30.

What conditions does trial NCT03057054 study?

This clinical trial studies the following conditions: Lymphoma, Leukemia, Hematopoietic and Lymphatic System Neoplasm, Acute Graft Versus Host Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03057054?

The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Placebo Administration (OTHER), Lactobacillus plantarum strain 299 (BIOLOGICAL), Lactobacillus plantarum strain 299v (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03057054?

This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03057054 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial