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Clinical Trials/NCT02940093
NCT02940093
Unknown
Not Applicable

Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management

University Hospital Tuebingen1 site in 1 country60 target enrollmentNovember 24, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stem Cell Transplantation
Sponsor
University Hospital Tuebingen
Enrollment
60
Locations
1
Primary Endpoint
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.
Last Updated
8 years ago

Overview

Brief Summary

The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.

Registry
clinicaltrials.gov
Start Date
November 24, 2016
End Date
October 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient (stem cell recipient) with hematological malignancies, age 3-18
  • Healthy allogeneic stem cell donor (identical or non-identical related donor)

Exclusion Criteria

  • Patients \<3 years of age
  • Patient who are unable to provide urine, stool or blood samples due to their medical condition

Outcomes

Primary Outcomes

Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.

Time Frame: through study completion, anticipated after 2 years

Study Sites (1)

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