Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics
Phase 2
- Conditions
- malignant lymphoma
- Registration Number
- JPRN-UMIN000017882
- Lead Sponsor
- Department of Medicine, Kobe University Hospital and Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
(1) History of stem cell transplantation (2) HIV carrier (3) Uncontrolled active infectious diseases (4) Pregnant or lactating (5) Uncontrolled psychological disorder (6) Allergy for the drugs used for the conditioning regimen (7) Allergy for Gfine (8) Patients who do not tolerate the maximal defined conditioning regimen due to organ dysfunction (e.g., reduce MCNU due to pulmonary dysfunction, reduce Carboplatin due to renal dysfunction) (9) Patients who do not ingest enough calories (10) Investigator rejection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of TP
- Secondary Outcome Measures
Name Time Method (1) Diarrhea and infectious diseases (2) Regimen related toxicity except diarrhea and infectious diseases (3) Engraftment (4) Effect of appetite hormone (5) Quality of life (6) GLP-2 blood level (7) Nutritional condition (8) Length of stay and Cost-effectiveness (9) Period of failure to TPN administer