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Probiotic

Probiotics for Preventing Graft-versus-Host Disease

Phase 3
Waitlist Available
Led By Michael L Nieder
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant
Be younger than 65 years old
Must not have
Patient plans on receiving stem cells from a matched (8/8) related donor
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days post stem cell infusion
Awards & highlights

Summary

This trial is testing whether Lactobacillus plantarum, a beneficial bacteria found in foods like yogurt, can prevent a serious gut complication called acute graft versus host disease in young patients receiving stem cell transplants. The bacteria may help by keeping the gut healthy and reducing inflammation. Lactobacillus plantarum has been used in human studies to promote beneficial effects in the immune system, alleviate intestinal disorders, and reduce the risk of cardiovascular disease. The study will compare patients taking Lactobacillus plantarum to those not taking it.

Who is the study for?
This trial is for children with leukemia, lymphoma, or other blood cancers who are undergoing a donor stem cell transplant. They must have good performance status and be receiving cells from a partially matched donor. Kids can't join if they're allergic to certain antibiotics, recently took probiotics, are pregnant, have active infections or severe GI issues.
What is being tested?
The study tests whether Lactobacillus plantarum strains (299 and 299v) can prevent acute graft versus host disease in the gut after stem cell transplants compared to a placebo. It's randomized: patients don't choose which treatment they get.
What are the potential side effects?
Possible side effects may include reactions related to gut health since Lactobacillus plantarum is involved with gastrointestinal function. Specific side effects will depend on how each child's body responds to the bacteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with a condition treated by a stem cell transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I plan to receive stem cells from a fully matched family member.
Select...
I have had severe gastrointestinal problems or surgeries in the past.
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I am not pregnant and have a negative pregnancy test.
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I am allergic to specific antibiotics used for treating blood infections.
Select...
I currently have diarrhea that tested positive for C. difficile.
Select...
I am currently on antibiotics for a bacterial infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 days post stem cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days post stem cell infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants With Stage 1-4 Gastrointestinal (GI) Acute Graft Versus Host Disease (aGVHD)
Other study objectives
Bacterial Genes and Pathways, and Bacterial Metabolites (Blood/Stool Measures of Intestinal Flora - Function and Phylogenetic Composition)
Blood/Stool Measures of Intestinal Flora Assessed Using Sequencing
Hospital Days
+6 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (Lactobacillus plantarum, alloHCT)Experimental Treatment3 Interventions
Patients 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.
Group II: Arm II (placebo, alloHCT)Placebo Group2 Interventions
Patients 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for leukemia include chemotherapy, which uses drugs to kill rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in cancer cell growth; immunotherapy, which boosts the body's immune system to fight cancer; and stem cell transplants, which replace diseased bone marrow with healthy cells. These treatments are crucial for leukemia patients as they aim to eliminate cancer cells, restore normal blood cell production, and prevent relapse. While probiotics like Lactobacillus plantarum are not directly used to treat leukemia, maintaining a healthy gut microbiota can support overall health and potentially improve the immune system's function, which is beneficial during cancer treatment.

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,657 Total Patients Enrolled
171 Trials studying Leukemia
103,069 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,827 Total Patients Enrolled
1,526 Trials studying Leukemia
385,154 Patients Enrolled for Leukemia
Michael L NiederPrincipal InvestigatorChildren's Oncology Group
~24 spots leftby Sep 2025
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