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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive careClosed18 and overNCI, Other060802
P30CA072720, CDR0000649274, CINJ-060802, PERFECT, NCT00946283

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

National Cancer Institute

Roger StrairPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00946283
Information obtained from ClinicalTrials.gov on November 20, 2012

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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