Status:
TERMINATED
Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Conditions:
Breast Cancer
Chronic Myeloproliferative Disorders
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief 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 we...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00946283
Start Date
March 1 2010
End Date
October 14 2015
Last Update
February 3 2017
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903