Graft versus host disease prevention/reduction by microbiome and patient blood management in allogeneic hematopoietic stem cell transplant patients

Phase 3

Recruiting

• Conditions: Condition 1: graft versus host disease. Condition 2: acute graft versus host disease.; Graft-versus-host disease; Acute graft-versus-host disease; D89.81; D89.810

• Registration Number: IRCT20190914044766N1
• Lead Sponsor: High Institute for Research and Education in Transfusion Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Candidates for allogeneic bone marrow transplant who have been referred for transplantation to Taleghani Hospital for treatment of blood malignancies
Age 20 to 50 years
The source of the transplanted tissue of all patients is peripheral blood stem cells
HLA transplanted tissue to be fully compatible with patient HLA (fully compatible with primary HLA A , B and DR-B1 )
The prophylaxis diet should be the same to prevent GVHD
All patients use irradiated blood and products

Exclusion Criteria

Patients who did not have allogeneic bone marrow transplantation
Patient dissatisfaction
Having an infection or fever above 38.5 ° C before entering the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of graft-versus-host disease (GVHD). Timepoint: They are followed up clinically for up to 100 days after transplantation. Method of measurement: Using clinical evidence that occurs in the patient and the physician's opinion.;The grade and severity of graft-versus-host disease. Timepoint: They are followed up clinically for up to 100 days after transplantation. Method of measurement: Using clinical evidence that occurs in the patient and the physician's opinion.;The rate and percentage of regulatory T in patients. Timepoint: Day 7 and 28 after transplantation. Method of measurement: ??? ?????????? ????????????.;Plasma levels of reg3a and ST-2. Timepoint: Day 7 and 28 after transplantation. Method of measurement: ELISA Laboratory Method.

Secondary Outcome Measures

Name	Time	Method
Improve and reduce gastrointestinal complications. Timepoint: Up to 10 days after transplant. Method of measurement: Patient clinical statements.