Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02940093
Acronym
ImMiGeNe
Enrollment
60
Registered
2016-10-20
Start date
2016-11-24
Completion date
2018-10-31
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stem Cell Transplantation

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.

Interventions

OTHERStem 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.

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactAlexander NR Weber, PhD
alexander.weber@uni-tuebingen.de+49 7071 29
Backup ContactSilke Peter, MD
silke.peter@med.uni-tuebingen.de+49 7071 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026