NCT06279065 Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
| NCT ID | NCT06279065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bonn |
| Condition | Giant Cell Arteritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2026-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-02-29 with a primary completion date of 2026-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06279065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06279065 currently recruiting?
Yes, NCT06279065 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Bonn to inquire about joining.
Where is the NCT06279065 trial being conducted?
This trial is being conducted at Bonn, Germany, Bonn, Germany.
Who is sponsoring the NCT06279065 clinical trial?
NCT06279065 is sponsored by University of Bonn. The trial plans to enroll 50 participants.