NIPH Clinical Trials Search

UMIN ID: UMIN000001339

Registered date:29/08/2008

Prospective randomized Phase II trial in nutritional support for autologous PBSCT Non-synbiotics vs Synbiotics

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedmalignant lymphoma or multiple myeloma
Date of first enrollment2008/09/01
Target sample size76
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intervention: Use of GFO and lactobacillus in patients who receive autologous PBSCT Standard : No Use of GFO and lactobacillus in patients who receive autologous PBSCT


Primary OutcomeProbability of more than grade 3 intestinal regimen related toxicity
Secondary Outcome(1) 1-year overall survival and event-free survival (2) Regimen related toxicity except intestinal toxicity (3) Engraftment (4) Infectious diseases (5) Duration of TPN (6) Dose and duration of intravenous morphine (7) Dose of insulin (8) Hyperglycemia and hypoglycemia (9) DAO activity

Key inclusion & exclusion criteria

Age minimum18years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude 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 GFO or lactobacillus (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)

Related Information


public contact
Name Shigeo Fuji
Address 2-6-40, Karasugatsuji, Tennoji-ku, Osaka-city, Osaka, 543-8922, Japan Japan
Telephone 0667737111
Affiliation NTT West Japan Osaka Hospital Department of Hematology
scientific contact
Name Sung-Won Kim
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan Japan
Telephone 03-3542-2511
Affiliation National Cancer Center Hospital Hematology and Stem Cell Transplantation