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Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome

Not Applicable
Terminated
Conditions
Leukemia
Lymphoma
Neuroblastoma
Testicular Germ Cell Tumor
Breast Cancer
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Chronic Myeloproliferative Disorders
Myelodysplastic/Myeloproliferative Neoplasms
Ovarian Cancer
Registration Number
NCT00946283
Lead Sponsor
Rutgers, The State University of New Jersey
Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Safety as indicated by the lack of infection attributable to probiotic organisms3 years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rutgers Cancer Institute of New Jersey

🇺🇸

New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States

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