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

Stem Cell Transplantation Clinical Trial

— ImMiGeNe  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940093
• Other study ID #: ImMiGeNe-001
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: November 10, 2017
• Start date: November 24, 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2017
• Source: University Hospital Tuebingen
• Contact: Alexander NR Weber, PhD
• Phone: +49 7071 29
• Email: alexander.weber[@]uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Stem Cell Transplantation

Intervention

Other:
• Stem cell transplantation
Intervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study.

Locations

Country	Name	City	State
Germany	University Children's Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.		through study completion, anticipated after 2 years

External Links

•   Link to ImMiGeNe project website