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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00946283
• Other study ID #: 060802
• Secondary ID: P30CA072720CDR00
• Status: Terminated
• Phase: N/A
• First received: July 23, 2009
• Last updated: February 2, 2017
• Start date: March 2010
• Est. completion date: October 14, 2015

Study information

• Verified date: February 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: October 14, 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Ovarian Cancer
• Plasmacytoma
• Preleukemia
• Syndrome
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG
Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as indicated by the lack of infection attributable to probiotic organisms		3 years