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

Prospective randomized Phase II trial in nutritional support for autologous PBSCT Non-synbiotics vs Synbiotics - NST02

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001339
Enrollment
76
Registered
2008-08-29
Start date
2008-09-01
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 or multiple myeloma

Interventions

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

Sponsors

National Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Malignant lymphoma or multiple myeloma 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 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)

Design outcomes

Primary

MeasureTime frame
Probability of more than grade 3 intestinal regimen related toxicity

Secondary

MeasureTime frame
(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

Countries

Japan

Contacts

Public ContactShigeo Fuji

NTT West Japan Osaka Hospital Department of Hematology

s-fuji@pj8.so-net.ne.jp0667737111

Outcome results

None listed

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