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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
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.


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

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 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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety as indicated by the lack of infection attributable to probiotic organisms [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome
  • Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count > 1000/μL for > 3 days without filgrastim (G-CSF) support within 30 days of transplant

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Serum creatinine ≤ 2.0
  • AST or ALT ≤ 3 times upper limit of normal (ULN)
  • Total bilirubin ≤ 2.0 times ULN
  • No clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
  • Able to take medications by mouth
  • No evidence of graft-vs-host disease
  • No history of inflammatory bowel disease or other chronic diarrheal illness
  • No history of hypersensitivity to milk proteins

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
  • No concurrent over-the-counter medications or herbal remedies

Information from the National Library of Medicine

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


Locations
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00946283     History of Changes
Other Study ID Numbers: 060802
P30CA072720 ( U.S. NIH Grant/Contract )
CDR0000649274 ( Other Identifier: NIH )
0220090096 ( Other Identifier: IRB )
NCI-2012-00597 ( Other Identifier: NCI )
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Rutgers, The State University of New Jersey:
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Breast Neoplasms
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Myeloproliferative Disorders
Plasmacytoma
Testicular Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders