Probiotics for Preventing Graft-versus-Host Disease

Not currently recruiting at 48 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Must not be taking: Probiotics, Antibiotics

Disqualifiers: Pregnancy, Severe GI issues, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the probiotic Lactobacillus plantarum can prevent acute graft-versus-host disease, a condition where donor stem cells attack the recipient's body, in children and young adults receiving a donor stem cell transplant. Participants will receive either the probiotic or a placebo to determine if the probiotic can protect their gut. This trial suits those with a condition treated with an alternative donor stem cell transplant who have not used probiotics in the last 30 days. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on antibiotics for an active bacterial infection, you may not be eligible to participate.

Is there any evidence suggesting that Lactobacillus plantarum is likely to be safe for humans?

Research has shown that giving Lactobacillus plantarum to children and teens undergoing donor stem cell transplants is safe. Studies have found that this probiotic does not cause harmful side effects in these patients. However, it has not succeeded in preventing gastrointestinal graft-versus-host disease, the goal of these trials. Overall, the treatment is well-tolerated, meaning patients do not experience significant negative reactions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for graft-versus-host disease, which typically involve immunosuppressive drugs, Lactobacillus plantarum is a probiotic that aims to prevent the condition by promoting a healthy gut flora. This approach is unique because it leverages beneficial bacteria to potentially reduce inflammation and boost the immune system's tolerance. Researchers are excited about this treatment because it offers a more natural way to manage the condition, potentially reducing reliance on drugs that can have significant side effects.

What evidence suggests that Lactobacillus plantarum might be an effective treatment for preventing graft-versus-host disease?

This trial will compare Lactobacillus plantarum with a placebo to determine its effectiveness in preventing gastrointestinal graft-versus-host disease (GI aGvHD) in patients undergoing stem cell transplants. Studies have shown that while L. plantarum is safe, it did not prevent this condition. The trials closely examined its effects but found no significant benefit in stopping GI aGvHD from developing. Although promising in theory, evidence from these studies suggests it does not effectively prevent the disease in this context. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael L Nieder

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

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.

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

I can do most activities or use a wheelchair due to a condition but not because of my current illness.

I am receiving cells from a donor who is either a perfect match or has only 1-2 mismatches.

Exclusion Criteria

I plan to receive stem cells from a fully matched family member.

I have had severe gastrointestinal problems or surgeries in the past.

I am not pregnant and have a negative pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplant Conditioning

Participants receive Lactobacillus plantarum or placebo starting on day 1 of the transplant conditioning regimen

Up to 56 days

Daily administration

Allogeneic Hematopoietic Cell Transplantation (alloHCT)

Participants undergo alloHCT at day 0

1 day

Post-Transplant Treatment

Continued administration of Lactobacillus plantarum or placebo until 56 days post alloHCT

56 days

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

120 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Lactobacillus Plantarum

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm I (Lactobacillus plantarum, alloHCT) Experimental Treatment 3 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 Group 2 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.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

astctjournal.org

astctjournal.org/article/S2666-6367(25)01141-8/fulltext

A Report From the Children's Oncology Group (ACCL1633)

We performed a Phase 3, randomized, placebo-controlled clinical trial to examine the effect of L. plantarum 299v (LBP 299v) in preventing GI ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40306553/

A Report From the Children's Oncology Group (ACCL1633)

We conclude that administration of LBP 299v is safe among children and adolescents undergoing alloHCT but ineffective at preventing GI aGvHD.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03057054

Study Details | NCT03057054 | Lactobacillus Plantarum in ...

Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2666636725011418

A Randomized Clinical Trial Evaluating Lactiplantibacillus ...

We conclude that administration of LBP 299v is safe among children and adolescents undergoing alloHCT but ineffective at preventing GI aGvHD.

5.

astctjournal.org

astctjournal.org/article/S2666-6367(25)01141-8/pdf

A Randomized Clinical Trial Evaluating Lactiplantibacillus ...

We present results of analyses of the effect of LBP 299v on GI aGvHD, on additional select exploratory clinical outcomes, and bio- markers for the integrity of ...