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

February 2, 2017 updated by: Rutgers, The State University of New Jersey

Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Culturelle DS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as indicated by the lack of infection attributable to probiotic organisms
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

October 14, 2015

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (ESTIMATE)

July 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060802
  • P30CA072720 (U.S. NIH Grant/Contract)
  • CDR0000649274 (OTHER: NIH)
  • 0220090096 (OTHER: IRB)
  • NCI-2012-00597 (OTHER: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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