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

January 15, 2026 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Impact of Intestinal Metabolome and Microbiome Disbalance of Recipients of Hematopoietic Transplant in the Development of Acute Graft Versus Host Disease.

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Marqués de Valdecillas, Santander
    • Córdoba
      • Córdoba, Córdoba, Spain
        • Hospital Universitario Reina Sofia
    • Granada
      • Granada, Granada, Spain
        • Hospital Virgen De Las Nieves De Granada
    • Madrid
      • Madrid, Madrid, Spain
        • Hospital del Niño Jesús, Madrid
      • Madrid, Madrid, Spain
        • Hospital La Paz, Madrid
    • Málaga
      • Málaga, Málaga, Spain
        • Hospital Regional Universitario de Málaga
    • Salamanca
      • Salamanca, Salamanca, Spain
        • Hospital Clínico de Salamanca
    • Seville
      • Seville, Seville, Spain
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, SEVILLA
    • Valencia
      • Valencia, Valencia, Spain
        • Hospital Clinico de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.

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).

Exclusion Criteria

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

Donors

Family donors from patients included in the study:

Inclusion criteria:

  • 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:

  • Unrelated donors
  • Transplants from umbilical cord blood source.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolome
Time Frame: From pre-Conditioning (Day -15) to Day +100 post-transplant.
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
Time Frame: From the day of transplant (Day 0) to Day +100 posttransplant.
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
Time Frame: From the day of transplant (Day 0) to 2 years posttransplant.
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
Time Frame: From the day of transplant (Day 0) to 2 years posttransplant.
Comparison of overall survival between obtained groups according to metabolome results.
From the day of transplant (Day 0) to 2 years posttransplant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome (alpha diversity of the intestinal microbiota)
Time Frame: At Day -15 and Day +30 post-transplant.
Comparison of biological alpha diversity of the intestinal microbiota. Calculation of alpha diversity (Shannon's diversity index, observed OTUs, Faith's Phylogenetic Diversity and Evenness) index by QIIME-
At Day -15 and Day +30 post-transplant.
Microbiome (beta diversity of the intestinal microbiota)
Time Frame: At Day -15 and Day +30 post-transplant.
Comparison of biological beta diversity of the intestinal microbiota. Calculation of beta diversity (Jaccard distance, Bray-Curtis distance, Unweighted UniFrac distance and Unweighted UniFrac distance) index by QIIME-
At Day -15 and Day +30 post-transplant.
Microbiome (alpha diversity of the plasmatic microbiota)
Time Frame: At Day -15 and Day +30 post-transplant.
Comparison of biological alpha diversity of the plasmatic microbiota. Calculation of alpha diversity (Shannon's diversity index, observed OTUs, Faith's Phylogenetic Diversity and Evenness) index by QIIME-
At Day -15 and Day +30 post-transplant.
Microbiome (beta diversity of the plasmatic microbiota)
Time Frame: At Day -15 and Day +30 post-transplant.
Comparison of biological beta diversity of the plasmatic microbiota. Calculation of beta diversity (Jaccard distance, Bray-Curtis distance, Unweighted UniFrac distance and Unweighted UniFrac distance) index by QIIME-
At Day -15 and Day +30 post-transplant.
Relapse
Time Frame: From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.
Comparison of patients´s incidence of relapse of the malignant disease between the groups obtained according to microbiome-metabolome results.
From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.
Mortality
Time Frame: From the day of transplant (Day 0) to Days +30, +100, +365 and two years posttransplant.
Comparison of patients mortality between the groups obtained according to microbiome-metabolome results.
From the day of transplant (Day 0) to Days +30, +100, +365 and two years posttransplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Ildefonso Espigado, PhD, Seville University, Dep. of Medicine. Virgen del Rocío/Virgen Macarena Hospitals, Instituto de Investigación Biomédica de Sevilla / CSIC, Seville, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2023

Primary Completion (Actual)

December 15, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlloBolome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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