Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis (GCA-Biom)

University of Bonn

Status

Enrolling

Conditions

Giant Cell Arteritis

Treatments

Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage)

Study type

Observational

Funder types

Other

Identifiers

NCT06279065

373/23-EP

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.