Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Analysis of blood and microbiome samples (stool, oral lavage).
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
Overview
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 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
Primary outcome measures
- Significant differences in the composition of the microbiome [Time frame: At Baseline and 6 month follow up]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Germany · 2 centers
- Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Cli — Bonn
- University Hospital Bonn — Bonn
Identifiers
NCT: NCT06279065 · 373/23-EP