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

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Breast Cancer; Multiple Myeloma and Plasma Cell Neoplasm; Neuroblastoma; Chronic Myeloproliferative Disorders; Lymphoma; Ovarian Cancer; Leukemia; Myelodysplastic Syndromes; Testicular Germ Cell Tumor; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Dietary Supplement: Lactobacillus rhamnosus GG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00946283

0220090096 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

060802

NCI-2012-00597 (Other Identifier)

CDR0000649274 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lactobacillus GG

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus rhamnosus GG