Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
Basic Trial Information
|No phase specified||Supportive care||Closed||18 and over||NCI, Other||060802|
P30CA072720, CDR0000649274, 0220090096, NCI-2012-00597, CINJ-060802, PERFECT, NCT00946283
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.
Further Study Information
- 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.
- 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
- 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 Contact Information
Trial Lead Organizations/Sponsors
Rutgers, The State University of New Jersey
- National Cancer Institute
- Rutgers, The State University of New Jersey
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00946283
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.