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Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics

Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics - Prospective, randomized, double-blind, placebo-controlled trial in nutritional support for autologous PBSCT Non-synbiotics vs synbiotics

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017882
Enrollment
12
Registered
2015-06-12
Start date
2015-08-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant lymphoma

Interventions

Synbiotics: Use of Gfine in patients who receive autologous PBSCT Placebo: Use of Placebo in patients who receive autologous PBSCT

Sponsors

Department of Medicine, Kobe University Hospital and Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Malignant lymphoma who can be candidate for autologous PBSCT (2) 17<Age<66 (3) ECOG PS <2 (4) No obvious organ failure (5) They have given written informed consent (6) Patients who will survive more than 3 months

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Duration of TPN

Secondary

MeasureTime frame
(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

Countries

Japan

Contacts

Public ContactYu Mizutani

Kobe University Hospital Medical Oncology/Hematology

mizuyu@med.kobe-u.ac.jp0783825111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026