Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT00946283|
Recruitment Status : Terminated (slow accrual)
First Posted : July 24, 2009
Last Update Posted : February 3, 2017
RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in patients with suppressed immune systems.
PURPOSE: This phase I trial is studying the side effects and how well giving enteral nutrition, including Lactobacillus, works in preventing infections in patients undergoing donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor||Dietary Supplement: Lactobacillus rhamnosus GG||Not Applicable|
- To determine if patients who are treated with a probiotic-containing diet develop infection with one of the probiotic microorganisms while undergoing allogenic hematopoietic stem cell transplantation for a hematologic malignancy or myelodysplastic syndrome.
OUTLINE: Patients receive oral Lactobacillus rhamosus GG (Culturelle DS) once daily beginning when blood counts have recovered without filgrastim (G-CSF) or sargramostim (GM-CSF) support for 3 consecutive days and continuing for 1 year after transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||October 14, 2015|
Experimental: Lactobacillus GG
Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation.
Dietary Supplement: Lactobacillus rhamnosus GG
Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water
Other Name: Culturelle DS
- Safety as indicated by the lack of infection attributable to probiotic organisms [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946283
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|