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Probiotic shows promise in preventing Life-Threatening transplant complication in kids

NCT ID NCT03057054

Prevention Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Lactobacillus plantarum can prevent a serious complication called graft-versus-host disease (GvHD) in the gut of children receiving a donor stem cell transplant. About 173 children with blood cancers or other conditions are taking the probiotic daily for several weeks after their transplant. The goal is to see if this simple treatment can reduce the risk of severe gut GvHD, which is a major cause of illness after transplant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

173 people

The number who actually took part.

Started

Apr 2018

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm leukemia lymphoma acute graft versus host disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute-graft-versus-host disease Hematopoietic and lymphatic system neoplasm Leukemia Lymphoma

Contacts and locations

Locations

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8, Canada

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207, United States

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    Orlando, Florida, 32827, United States

  • New York Medical College

    Valhalla, New York, 10595, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203, United States

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.