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
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG

• 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.

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2010-03
• Primary Completion: 2013-05
• Study Completion: 2015-10-14
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

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

Arm && Interventions

Group	Intervention	Description
Lactobacillus GG	Lactobacillus rhamnosus GG	Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Safety as indicated by the lack of infection attributable to probiotic organisms	3 years

Trial Locations

Locations (1)

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