NCT Number: NCT05186857
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.
This study is active but is not currently recruiting participants.
Notify Me1 year–100 year
All sexes
Observational
Hospital Marqués de Valdecillas, Santander, Santander, Cantabria, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Patients Patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period.
Inclusion criteria
Exclusion criteria
Donors
Family donors from patients included in the study:
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: From the day of transplant (Day 0) to 2 years posttransplant.
Comparison of overall survival between obtained groups according to metabolome results.
Time frame: From the day of transplant (Day 0) to 2 years posttransplant.
Comparison of overall survival between obtained groups according to metabolome results.
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-
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-
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-
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-
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.
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.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Other
Impact of Intestinal Metabolome and Microbiome Disbalance of Recipients of Hematopoietic Transplant in the Development of Acute Graft Versus Host Disease.
Acronym: AlloBolome
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