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

NCT06279065 | Recruiting

• 1 other identifier: 373/23-EP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Giant Cell Arteritis

Keywords

microbiome

Outcome Measures

Primary Outcomes (1)

• Significant differences in the composition of the microbiome

  At Baseline and 6 month follow up

Secondary Outcomes (2)

• 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

• potential association of microbiome composition with application of immune modulating drugs

  At Baseline and 6 month follow up

Study Arms (2)

GCA Patients

Primary diagnosis of giant cell arteritis

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

Control

Control group without rheumatologic disease

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

Interventions

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

Control; GCA Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

no specific requirements, usually over 50 years

You may qualify if:

• Diagnosis of Giant cell arteritis (only in one arm)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (2)

Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Blood, oral Lavage

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Defecation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the rheumatology department, University Hospital Bonn

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 26, 2024
• Study Start: February 29, 2024
• Primary Completion: February 18, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)