RecruitingNCT06279065

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


Sponsor

University of Bonn

Enrollment

50 participants

Start Date

Feb 29, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Diagnosis of Giant cell arteritis (only in one arm)

Exclusion Criteria11

  • 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.

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Interventions

DIAGNOSTIC_TESTAnalysis 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

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NCT06279065


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