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

NCT ID: NCT02940093

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-24

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stem cell transplant recipient

Stem cell transplantation

Intervention Type OTHER

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.

Stem cell donor

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander NR Weber, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Children's Hospital Tübingen

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alexander NR Weber, PhD

Role: CONTACT

Phone: +49 7071 29

Email: [email protected]

Silke Peter, MD

Role: CONTACT

Phone: +49 7071 29

Email: [email protected]

Facility Contacts

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Peter Lang, MD

Role: primary

Other Identifiers

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ImMiGeNe-001

Identifier Type: -

Identifier Source: org_study_id