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RECRUITINGOBSERVATIONAL

Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis

Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.

Who May Be Eligible (Plain English)

Who May Qualify: • Diagnosis of Giant cell arteritis (only in one arm) Who Should NOT Join This Trial: - chronic infection (viral, fungi, bacteria) including human weakened immune system viruses, Hepatitis B/C - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: • Diagnosis of Giant cell arteritis (only in one arm) Exclusion Criteria: * chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B/C * 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.

Treatments Being Tested

DIAGNOSTIC_TEST

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

Locations (2)

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