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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 days post stem cell infusion
Awards & highlights

Study Summary

This trial looks at whether a certain type of bacteria can help prevent a serious complication in children who have had a stem cell transplant from a donor.

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.Check my eligibility
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.See study design
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
Select...
I am diagnosed with a condition treated by a stem cell transplant from a donor.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Participants With Stage 1-4 Gastrointestinal (GI) Acute Graft Versus Host Disease (aGVHD)
Other outcome measures
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
~1200

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,527 Total Patients Enrolled
171 Trials studying Leukemia
103,099 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,980 Total Patients Enrolled
1,512 Trials studying Leukemia
384,509 Patients Enrolled for Leukemia
Michael L NiederPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it safe to say that Allogeneic Hematopoietic Stem Cell Transplantation is backed by the FDA?

"Allogeneic Hematopoietic Stem Cell Transplantation is considered safe, as it has advanced to Phase 3 in clinical trials. This means that there is efficacy data supporting the intervention and multiple rounds of safety data."

Answered by AI

Does this trial have an age limit? If so, what is it?

"The age range for this particular study is 2 to 25. There are 695 other clinical trials underway for individuals under 18 and 3,335 studies available for patients over 65."

Answered by AI

What types of blood diseases does Allogeneic Hematopoietic Stem Cell Transplantation help to ameliorate?

"Allogeneic Hematopoietic Stem Cell Transplantation is often used to improve gut health, but it can also be a helpful form of therapy for treating vulvovaginitis, chemotherapy side effects, and bacterial infections."

Answered by AI

Are we still recruiting patients for this experiment?

"This trial, as documented on clinicaltrials.gov, is no longer actively recruiting patients. It was initially posted on April 30th, 2018 but has not been updated since July 20th, 2022. Although this study is closed to new participants, there are 3749 other trials that remain open and are currently looking for volunteers."

Answered by AI

How many patients will be enrolled in this clinical trial?

"This study is no longer enrolling participants. It was initially posted on April 30th, 2018 and last updated on July 20th, 2022. If you are seeking other trials, there are 3747 active clinical studies for lymphoma patients and 2 trials for Allogeneic Hematopoietic Stem Cell Transplantation recruiting right now."

Answered by AI

In how many different geographical areas is this medical study being run today?

"41 patients are currently enrolled in this study, with locations including the Alberta Children's Hospital in Calgary, UCSF Benioff Children's Hospital Oakland in Oakland, Helen DeVos Children's Hospital at Spectrum Health in Grand Rapids, as well as 41 other sites."

Answered by AI

Are there other ongoing research projects that use Allogeneic Hematopoietic Stem Cell Transplantation?

"At this time, there are two ongoing clinical trials involving allogeneic hematopoietic stem cell transplantation. Of these, two are in Phase 3. Most of the trials for allogeneic hematopoietic stem cell transplantation are taking place in New york City; however, there are 51 total locations running such studies."

Answered by AI

How can I sign up to be a participant in this clinical trial?

"This study is looking for 167 participants between the ages of 2 and 25 who have lymphoma. To be eligible, patients must also meet the following 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 >="

Answered by AI
~25 spots leftby Apr 2025