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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06279065

Acronym

GCA-Biom

Enrollment

Registered

2024-02-26

Start date

2024-02-29

Completion date

2028-02-29

Last updated

2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

microbiome

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.

Interventions

DIAGNOSTIC_TESTAnalysis 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 design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Significant differences in the composition of the microbiome	At Baseline and 6 month follow up

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026