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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190914044766N1

Enrollment

Registered

2020-01-28

Start date

2020-01-21

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

Condition 1: graft versus host disease. Condition 2: acute graft versus host disease. Graft-versus-host disease Acute graft-versus-host disease

Interventions

Intervention 1: Intervention group: Intervention group:20 Patients reported for allogeneic bone marrow transplantation: who consume one day of graft probiotic capsule daily for 21 days before transpl

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Yazdandoust

high institute for research and education in transfusion medicine

yazdandouste@gmail.com+98 21 8860 1586

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026