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

NCT05186857 | Active Not Recruiting

• 1 other identifier: AlloBolome
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 9

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

Keywords

Acute graft-versus-host disease; Microbiome; Metabolome; Hematopoietic transplant

Outcome Measures

Primary Outcomes (4)

• Metabolome

  Sequential pre-transplant/post-transplant modifications in faecal and plasmatic levels of: 1.a. Butyrate (targeted analysis), 1.b: Biliary acids (targeted analysis) and 1.c. Metabolomic signature (untargeted analysis).

  From pre-Conditioning (Day -15) to Day +100 post-transplant.

• Incidence of Acute graft versus host disease

  Comparison of the incidence of any degree, degree-II and degree-III/IV of acute graft versus host disease between sub-groups of patients defined according to obtained metabolome results.

  From the day of transplant (Day 0) to Day +100 posttransplant.

• Overall Survival

  Comparison of overall survival between obtained groups according to metabolome results.

  From the day of transplant (Day 0) to 2 years posttransplant.

• Disease free survival

  Comparison of overall survival between obtained groups according to metabolome results.

  From the day of transplant (Day 0) to 2 years posttransplant.

Secondary Outcomes (6)

• Microbiome (alpha diversity of the intestinal microbiota)

  At Day -15 and Day +30 post-transplant.

• Microbiome (beta diversity of the intestinal microbiota)

  At Day -15 and Day +30 post-transplant.

• Microbiome (alpha diversity of the plasmatic microbiota)

  At Day -15 and Day +30 post-transplant.

• Microbiome (beta diversity of the plasmatic microbiota)

  At Day -15 and Day +30 post-transplant.

• Relapse

  From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.

Eligibility Criteria

• Age: 1 Year - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving an allotransplant and family donors of the included patients.

You may qualify if:

• 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).

You may not qualify if:

• \- Allotransplant recipients in stages after the initial pre-conditioning.
• Donors
• Family donors from patients included in the study:
• 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).
• Unrelated donors
• Transplants from umbilical cord blood source.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (9)

Hospital Marqués de Valdecillas, Santander

Santander, Cantabria, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital Virgen de las Nieves de Granada

Granada, Granada, Spain

Location

Hospital del Niño Jesús, Madrid

Madrid, Madrid, Spain

Location

Hospital La Paz, Madrid

Madrid, Madrid, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Salamanca, Spain

Location

Hospital Universitario Virgen del Rocío, Sevilla

Seville, Seville, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Ildefonso Espigado, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 11, 2022
• Study Start: January 23, 2023
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ES (9)