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)
5 other identifiers
interventional
173
2 countries
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2018
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
April 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedResults Posted
Study results publicly available
July 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedOctober 6, 2025
September 1, 2025
4.2 years
February 15, 2017
May 31, 2023
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Stage 1-4 Gastrointestinal (GI) Acute Graft Versus Host Disease (aGVHD)
The proportion of eligible patients having stage 1-4 GI aGvHD occur from Day 0 through Day 120 will be compared between the two arms.
Up to 120 days post stem cell infusion
Other Outcomes (9)
Incidence of Grade II-IV Overall Graft Versus Host Disease
Up to 120 days post stem cell infusion
Incidence of Blood Stream Infection
Up to 120 days post stem cell infusion
Incidence of Clostridium Difficile (C. Diff)-Associated Diarrhea
Up to 120 days post stem cell infusion
- +6 more other outcomes
Study Arms (2)
Arm I (Lactobacillus plantarum, alloHCT)
EXPERIMENTALPatients receive Lactobacillus plantarum strains 299 and 299v PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Arm II (placebo, alloHCT)
PLACEBO COMPARATORPatients receive placebo PO or through NJ, NG or G tube QD on day 1 of transplant conditioning regimen to 56 days post alloHCT. Patients undergo alloHCT at day 0.
Interventions
Undergo alloHCT
Given PO or via NJ, NG or G tube
Given PO or via NJ, NG or G tube
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment
- Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive
- Patient is receiving antibiotic therapy for an active bacterial infection
- Patient is allergic to all third or fourth generation cephalosporins, carbapenems, and all aminoglycosides, which are used to empirically treat LBP bacteremia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (43)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06520, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
New York Medical College
Valhalla, New York, 10595, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Nieder
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 17, 2017
Study Start
April 30, 2018
Primary Completion
June 30, 2022
Study Completion (Estimated)
June 30, 2026
Last Updated
October 6, 2025
Results First Posted
July 17, 2023
Record last verified: 2025-09