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

Launched by UNIVERSITY OF BONN · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how the human microbiome, especially the bacteria in our gut, may affect the development and progression of Giant Cell Arteritis (GCA), a condition that causes inflammation in the blood vessels. Researchers will compare the microbiomes of people diagnosed with GCA to those of healthy individuals at the time of diagnosis and again after six months. By doing this, they hope to identify specific bacteria that may influence the immune system and contribute to GCA.

To participate in this trial, individuals must be diagnosed with Giant Cell Arteritis and be between the ages of 65 and 74. However, certain health conditions, like chronic infections or gastrointestinal diseases, may exclude someone from participating. If eligible, participants will provide samples of their oral, blood, and gut microbiomes, which will be analyzed to better understand the role of these microorganisms. It's a chance to contribute to important research that could lead to new insights into this condition.

Gender

ALL

Eligibility criteria

• 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.