Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
NCT ID: NCT06279065
Last Updated: 2024-05-09
Study Results
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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RECRUITING
50 participants
OBSERVATIONAL
2024-02-29
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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GCA Patients
Primary diagnosis of giant cell arteritis
Analysis of blood and microbiome samples (stool, oral lavage)
Analysis of blood and microbiome samples (stool, oral lavage) especially composition of the gut microbiome and potential interaction with immune cells
Control
Control group without rheumatologic disease
Analysis of blood and microbiome samples (stool, oral lavage)
Analysis of blood and microbiome samples (stool, oral lavage) especially composition of the gut microbiome and potential interaction with immune cells
Interventions
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Analysis of blood and microbiome samples (stool, oral lavage)
Analysis of blood and microbiome samples (stool, oral lavage) especially composition of the gut microbiome and potential interaction with immune cells
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* acute infection with usage of antibiotics less then 90 days before screening
* major gastro-intestinal surgery \<5 years from screening
* gastro-intestinal bleeding \<90 days before screening
* inflammatory bowel disease (confirmed bioptically)
* bulimia or anorexia nervosa
* adipositas (body mass index ≥ 40)
* intake of high dosage of probiotics (\>10\^9 colony forming units per day) \<90 days before screening
* not controlled Diabetes mellitus
* Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)
* known abuse of alcohol oder drugs.
18 Years
ALL
Yes
Sponsors
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University of Bonn
OTHER
Responsible Party
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Valentin Schäfer
Head of the rheumatology department, University Hospital Bonn
Locations
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Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
University Hospital Bonn
Bonn, , Germany
Countries
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Facility Contacts
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Other Identifiers
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373/23-EP
Identifier Type: -
Identifier Source: org_study_id
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