Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
Study Details
Study Description
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 well giving enteral nutrition, including Lactobacillus, works in preventing infections in patients undergoing donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lactobacillus GG Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation. |
Dietary Supplement: Lactobacillus rhamnosus GG
Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety as indicated by the lack of infection attributable to probiotic organisms [3 years]
Eligibility Criteria
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:
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ECOG performance status 0-2
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Serum creatinine ≤ 2.0
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AST or ALT ≤ 3 times upper limit of normal (ULN)
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Total bilirubin ≤ 2.0 times ULN
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No clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
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Able to take medications by mouth
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No evidence of graft-vs-host disease
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No history of inflammatory bowel disease or other chronic diarrheal illness
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No history of hypersensitivity to milk proteins
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
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More than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
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No concurrent over-the-counter medications or herbal remedies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Cancer Institute (NCI)
- Rutgers Cancer Institute of New Jersey
Investigators
- Principal Investigator: Roger Strair, MD, PhD, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 060802
- P30CA072720
- CDR0000649274
- 0220090096
- NCI-2012-00597