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NCT03057054Active, not recruitingPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 6 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
173 (actual)
First submitted
15 Feb 2017
Start date
30 Apr 2018
Primary completion date
30 Jun 2022
Lead sponsor
Children's Oncology Group
NCT number
NCT03057054

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 173
  • From 30 Apr 2018 to the primary completion date, 30 Jun 2022
  • 43 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient plans on receiving stem cells from a matched (8/8) related donor
  • Patient has used a probiotic dietary supplement within the previous 30 days of enrollment; (consumption of yogurt products is allowed)
  • Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn's disease, ulcerative colitis), history of gastrointestinal GVHD, or history of bowel resection
  • Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment
  • Patient is receiving antibiotic therapy for an active bacterial infection

Other illness

  • Patient has a medical, psychiatric or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
  • Patient is allergic to all third or fourth generation cephalosporins, carbapenems, and all aminoglycosides, which are used to empirically treat LBP bacteremia

Other

  • Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive

Who the study is looking for

  • All clinical and laboratory studies, if applicable, must be obtained within 21 days prior to start of protocol therapy (repeat if necessary); protocol therapy must begin within 6 months of study enrollment
  • Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant
  • Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 70; patients who are unable to walk because of a chronic underlying condition (such as paralysis), but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score
  • Hematopoietic cell transplant (HCT)
    • Patient must be receiving cells from alternative donor defined as one of the following:
    • Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch, considering only HLA-A, HLA-B, HLA-C, and HLA-DRB1
    • Related donor with a 1 or more HLA mismatch (including haplo-identical)
    • Note: History of HCT or other cellular therapy (e.g. chimeric antigen receptor \[CAR\]-T cells, donor lymphocyte infusions) is permitted

Age in the registry: 2 years to 25 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (43)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alberta Children's Hospital
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CalgaryCanadaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
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MontrealCanadaUnknown status
Hospital for Sick Children
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TorontoCanadaUnknown status
C S Mott Children's Hospital
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Ann ArborUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Johns Hopkins University/Sidney Kimmel Cancer Center
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BaltimoreUnited StatesUnknown status
Children's Hospital of Alabama
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BirminghamUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Roswell Park Cancer Institute
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BuffaloUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
Medical City Dallas Hospital
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DallasUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
University of Florida Health Science Center - Gainesville
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GainesvilleUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand RapidsUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
Kapiolani Medical Center for Women and Children
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HonoluluUnited StatesUnknown status
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Nemours Children's Clinic-Jacksonville
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JacksonvilleUnited StatesUnknown status
Children's Mercy Hospitals and Clinics
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Kansas CityUnited StatesUnknown status
Children's Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center - University Hospital
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MadisonUnited StatesUnknown status
The Children's Hospital at TriStar Centennial
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NashvilleUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Children's Hospital New Orleans
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New OrleansUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New YorkUnited StatesUnknown status
UCSF Benioff Children's Hospital Oakland
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OaklandUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Nemours Children's Hospital
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OrlandoUnited StatesUnknown status
Children's Hospital of Philadelphia
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PhiladelphiaUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Methodist Children's Hospital of South Texas
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San AntonioUnited StatesUnknown status
Children's Hospital of San Antonio
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San AntonioUnited StatesUnknown status
Rady Children's Hospital - San Diego
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San DiegoUnited StatesUnknown status
UCSF Medical Center-Mission Bay
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San FranciscoUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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St. PetersburgUnited StatesUnknown status
New York Medical College
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ValhallaUnited StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status
Alfred I duPont Hospital for Children
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.