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

Giant Cell Arteritis Clinical Trial

— GCA-Biom  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279065
• Other study ID #: 373/23-EP
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: February 2028

Study information

• Verified date: May 2024
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2028
• Est. primary completion date: February 18, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant differences in the composition of the microbiome		At Baseline and 6 month follow up
Secondary	Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species		At Baseline and 2 year follow up
Secondary	potential association of microbiome composition with application of immune modulating drugs		At Baseline and 6 month follow up