Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant

NCT ID: NCT05186857

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2026-12-31

Brief Summary

Recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-SCT) recipients might influence incidence and severity of acute graft versus host disease (aGVHD). Nevertheless, this possible relationship has not been undoubtedly established, pathophysiologic mechanisms have not been elucidated and possible clinical implications have not been studied. We hypothesized that in the early phase of allo-SCT, specific alterations in faecal metabolome occurred related to loss of intestinal microbiota diversity and disbalance of specific bacterial taxa, and that both alterations determine reduced survival of patients through increased incidence and severity of aGVHD. To test this hypothesis, a prospective multi-center cohort of allo-SCT recipients will had faecal and plasmatic samples collected at predetermined time-points pre&post-allo-SCT, and clinical relevant variables will be prospectively recorded throughout two years posttransplant follow-up. Metabolomic and microbiome analysis will be done to answer objectives of the study. To additionally explore if differential evolving characteristics in the intestinal metabolome and microbiome of donor/recipient sibling pairs influence the incidence and severity of aGVHD, probability of malignancy relapse and early and late mortality an additional cohort of family donors of enrolled patients will also have faecal and plasmatic samples collected and analysed.

Conditions

Graft-versus-host Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis.
• Agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable).

• Agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable).
• Donor relatives with any degree of identity in the Human Leukocyte Antigens (HLA).

Exclusion Criteria

• Allotransplant recipients in stages after the initial pre-conditioning.

Donors

Family donors from patients included in the study:

• Unrelated donors
• Transplants from umbilical cord blood source.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ildefonso Espigado, PhD

Role: PRINCIPAL_INVESTIGATOR

Seville University, Dep. of Medicine. Virgen del Rocío/Virgen Macarena Hospitals, Instituto de Investigación Biomédica de Sevilla / CSIC, Seville, Spain

Locations

Hospital Marqués de Valdecillas, Santander

Santander, Cantabria, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Virgen de las Nieves de Granada

Granada, Granada, Spain

Hospital del Niño Jesús, Madrid

Madrid, Madrid, Spain

Hospital La Paz, Madrid

Madrid, Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Hospital Clínico de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario Virgen del Rocío, Sevilla

Seville, Seville, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

AlloBolome

Identifier Type: -

Identifier Source: org_study_id