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

NCT06279065 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Bonn

Phase

Observational

Started

2024-02-29

Last updated

2024-05-09

Condition(s) studied

Giant Cell Arteritis

Investigational drug(s) / intervention(s)

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

Analysis 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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Significant differences in the composition of the microbiome — At Baseline and 6 month follow up

Trial sites (2)

Facility	City	Region	Status
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn	Bonn	North Rhine-Westphalia	Recruiting
University Hospital Bonn	Bonn	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06279065 on ClinicalTrials.gov ↗ ← All trials in Germany