Graft-versus-host DiseaseAlloBolomeNCT05186857
Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant
An observational study of Graft-versus-host Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 9 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Graft-versus-host Disease
- How many people
- 88 participants
- Where
- 9 sitesSpain
- Study dates
- 23 Jan 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients receiving an allotransplant and family donors of the included patients.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Universitario Reina Sofía
Córdoba, Córdoba
Hospital Virgen de las Nieves de Granada
Granada, Granada
Hospital del Niño Jesús, Madrid
Madrid, Madrid
Hospital La Paz, Madrid
Madrid, Madrid
Hospital Regional Universitario de Málaga
Málaga, Málaga
Hospital Clínico de Salamanca
Salamanca, Salamanca
Hospital Marqués de Valdecillas, Santander
Santander, Cantabria
Hospital Universitario Virgen del Rocío, Sevilla
Seville, Seville
Hospital Clínico de Valencia
Valencia, Valencia
About this study
Official title: 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.
- Conditions
- Graft-versus-host Disease
- Keywords
- Acute graft-versus-host disease, Microbiome, Metabolome, Hematopoietic transplant
- Medical subject headings
- Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From the day of transplant (Day 0) to Day +100 posttransplant.
Overall Survival
Comparison of overall survival between obtained groups according to metabolome results.
Measured: 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.
Measured: From the day of transplant (Day 0) to 2 years posttransplant.
Secondary outcomes (6)
Microbiome (alpha diversity of the intestinal microbiota)
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-
Measured: At Day -15 and Day +30 post-transplant.
Microbiome (beta diversity of the intestinal microbiota)
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-
Measured: At Day -15 and Day +30 post-transplant.
Microbiome (alpha diversity of the plasmatic microbiota)
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-
Measured: At Day -15 and Day +30 post-transplant.
Microbiome (beta diversity of the plasmatic microbiota)
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-
Measured: At Day -15 and Day +30 post-transplant.
Relapse
Comparison of patients´s incidence of relapse of the malignant disease between the groups obtained according to microbiome-metabolome results.
Measured: From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.
Mortality
Comparison of patients mortality between the groups obtained according to microbiome-metabolome results.
Measured: From the day of transplant (Day 0) to Days +30, +100, +365 and two years posttransplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Jan 2023
- Primary completion15 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Ildefonso Espigado, PhD, Principal investigator, Seville University, Dep. of Medicine. Virgen del Rocío/Virgen Macarena Hospitals, Instituto de Investigación Biomédica de Sevilla / CSIC, Seville, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186857
- Sponsor's protocol ID
- AlloBolome
- Acronym
- AlloBolome
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2021
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intestinal Metabolome and Microbiome Disbalance of Recipients of Hematopoietic Transplant in the Development of Acute Graft Versus Host Disease.
- ClinicalTrials.gov ID
- NCT05186857
- Acronym / sponsor ID
- AlloBolome / AlloBolome
- Conditions
- Graft-versus-host Disease
- Keywords
- Acute graft-versus-host disease, Microbiome, Metabolome, Hematopoietic transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving an allotransplant and family donors of the included patients.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- Allotransplant recipients in stages after the initial pre-conditioning.
- Donors
- Unrelated donors
- Transplants from umbilical cord blood source.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
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.
6 secondary outcomes
Microbiome (alpha diversity of the intestinal microbiota)
Time frame: 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.
Microbiome (alpha diversity of the plasmatic microbiota)
Time frame: 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.
Relapse
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildefonso Espigado, PhD principal investigator
Seville University, Dep. of Medicine. Virgen del Rocío/Virgen Macarena Hospitals, Instituto de Investigación Biomédica de Sevilla / CSIC, Seville, Spain
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-versus-host Disease, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolome (time frame: From pre-Conditioning (Day -15) to Day +100 post-transplant.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.