Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers (ImMiGeNe)

University Hospital Tuebingen

Status: Unknown

Conditions: Stem Cell Transplantation

Treatments: Other: Stem cell transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT02940093

ImMiGeNe-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Stem cell transplant recipient

Treatment:

Other: Stem cell transplantation

Stem cell donor