Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-19 @ 3:50 AM
Study NCT ID:
NCT05186857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2021-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolome', 'timeFrame': 'From pre-Conditioning (Day -15) to Day +100 post-transplant.', 'description': '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).'}, {'measure': 'Incidence of Acute graft versus host disease', 'timeFrame': 'From the day of transplant (Day 0) to Day +100 posttransplant.', 'description': '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.'}, {'measure': 'Overall Survival', 'timeFrame': 'From the day of transplant (Day 0) to 2 years posttransplant.', 'description': 'Comparison of overall survival between obtained groups according to metabolome results.'}, {'measure': 'Disease free survival', 'timeFrame': 'From the day of transplant (Day 0) to 2 years posttransplant.', 'description': 'Comparison of overall survival between obtained groups according to metabolome results.'}], 'secondaryOutcomes': [{'measure': 'Microbiome (alpha diversity of the intestinal microbiota)', 'timeFrame': 'At Day -15 and Day +30 post-transplant.', 'description': "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-"}, {'measure': 'Microbiome (beta diversity of the intestinal microbiota)', 'timeFrame': 'At Day -15 and Day +30 post-transplant.', 'description': '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-'}, {'measure': 'Microbiome (alpha diversity of the plasmatic microbiota)', 'timeFrame': 'At Day -15 and Day +30 post-transplant.', 'description': "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-"}, {'measure': 'Microbiome (beta diversity of the plasmatic microbiota)', 'timeFrame': 'At Day -15 and Day +30 post-transplant.', 'description': '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-'}, {'measure': 'Relapse', 'timeFrame': 'From the day of transplant (Day 0) to +30, +100, +365 and two years posttransplant.', 'description': 'Comparison of patients´s incidence of relapse of the malignant disease between the groups obtained according to microbiome-metabolome results.'}, {'measure': 'Mortality', 'timeFrame': 'From the day of transplant (Day 0) to Days +30, +100, +365 and two years posttransplant.', 'description': 'Comparison of patients mortality between the groups obtained according to microbiome-metabolome results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute graft-versus-host disease', 'Microbiome', 'Metabolome', 'Hematopoietic transplant'], 'conditions': ['Graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving an allotransplant and family donors of the included patients.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.\n\nInclusion Criteria:\n\n* Patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis.\n* Agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable).\n\nExclusion Criteria\n\n\\- Allotransplant recipients in stages after the initial pre-conditioning.\n\nDonors\n\nFamily donors from patients included in the study:\n\nInclusion criteria:\n\n* Agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable).\n* Donor relatives with any degree of identity in the Human Leukocyte Antigens (HLA).\n\nExclusion Criteria:\n\n* Unrelated donors\n* Transplants from umbilical cord blood source.'}, 'identificationModule': {'nctId': 'NCT05186857', 'acronym': 'AlloBolome', 'briefTitle': 'Metabolome and Microbiome Impact on Acute GVHD in Recipients of Hematopoietic Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla'}, 'officialTitle': 'Impact of Intestinal Metabolome and Microbiome Disbalance of Recipients of Hematopoietic Transplant in the Development of Acute Graft Versus Host Disease.', 'orgStudyIdInfo': {'id': 'AlloBolome'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío, Sevilla', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves de Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital del Niño Jesús, Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz, Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Marqués de Valdecillas, Santander', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ildefonso Espigado, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seville University, Dep. of Medicine. Virgen del Rocío/Virgen Macarena Hospitals, Instituto de Investigación Biomédica de Sevilla / CSIC, Seville, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la gestión de la Investigación en Sevilla', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}