This trial is active, not recruiting.

Conditions breast cancer, chronic myeloproliferative disorders, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms, neuroblastoma, ovarian cancer, testicular germ cell tumor
Treatment lactobacillus rhamnosus gg
Sponsor Rutgers, The State University of New Jersey
Collaborator National Cancer Institute (NCI)
Start date March 2010
End date May 2013
Trial size 30 participants
Trial identifier NCT00946283, 0220090096, 060802, CDR0000649274, NCI-2012-00597, P30CA072720


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation.
lactobacillus rhamnosus gg Culturelle DS
Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water

Primary Outcomes

Safety as indicated by the lack of infection attributable to probiotic organisms
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
Principal investigator Roger Strair, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.