Exploring how the gut microbiome affects giant cell arteritis
Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
This study looks at how the bacteria in the gut might affect people with giant cell arteritis to see if they can find clues for better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bonn Academic / other |
| Locations | 2 sites (Bonn, North Rhine-Westphalia and 1 other locations) |
| Trial ID | NCT06279065 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of the human microbiome, particularly the gut microbiome, in the onset and progression of giant cell arteritis (GCA). It involves analyzing microbiome samples from patients diagnosed with GCA and healthy controls at the time of diagnosis and again after six months. The study aims to identify specific microbial communities that may influence the immune response related to GCA. By understanding these interactions, researchers hope to uncover potential biomarkers or therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with giant cell arteritis.
Not a fit: Patients with chronic infections, major gastrointestinal surgeries, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the treatment and management of giant cell arteritis by targeting the microbiome.
How similar studies have performed: While the role of the microbiome in various diseases is being explored, this specific investigation into giant cell arteritis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bonn, North Rhine-Westphalia and 1 other locations
- Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (Recruiting)
- University Hospital Bonn — Bonn, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.