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

• Conditions: Stem Cell Transplantation
• Interventions: Other: Stem cell transplantation

• Registration Number: NCT02940093
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Study Start: 2016-11-24
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-10
• Last Update Posted: 2017-11-14
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stem cell transplant recipient	Stem cell transplantation	-

Primary Outcome Measures

Name	Time	Method
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.	through study completion, anticipated after 2 years

Trial Locations

Locations (1)

University Children's Hospital Tübingen; 🇩🇪 Tübingen, Germany