Trials / Terminated
TerminatedNCT00946283
Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Rutgers, The State University of New Jersey · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus rhamnosus GG | Culturelle DS (Lactobacillus GG) will be administered one capsule (10 billion live lactobacillus GG) daily with water |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2013-05-01
- Completion
- 2015-10-14
- First posted
- 2009-07-24
- Last updated
- 2017-02-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00946283. Inclusion in this directory is not an endorsement.