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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

Analysis of blood and microbiome samples (stool, oral lavage) especially composition of the gut microbiome and potential interaction with immune cells

Primary outcomes

Significant differences in the composition of the microbiome

Time frame: At Baseline and 6 month follow up

Secondary outcomes

Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species

Time frame: At Baseline and 2 year follow up
potential association of microbiome composition with application of immune modulating drugs

Time frame: At Baseline and 6 month follow up

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Registry information

Official study title

Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis

Acronym: GCA-Biom

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2028
First posted: Feb 26, 2024
Registry last updated: May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting