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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-10-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Lactobacillus GG

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

Group Type EXPERIMENTAL

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water

Interventions

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Lactobacillus rhamnosus GG

Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Culturelle DS

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No