Giant Cell ArteritisGCA-BiomNCT06279065
Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis
An observational study of Giant Cell Arteritis, run by University of Bonn at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Analysis of blood and microbiome samples (stool, oral lavage)
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- 29 Feb 2024to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: no specific requirements, usually over 50 years
Who may be able to join
- Diagnosis of Giant cell arteritis (only in one arm)
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Valentin S. Schäfer, Dr. med., +49 228 287-17000, rheumatologie@ukbonn.de
- Recruiting
University Hospital Bonn
Bonn, 53127
Valentin Schäfer, MD, +28 287 17000, rheumatologie@ukbonn.de
Maike Adamson, +28 287 17000, rheumatologie@ukbonn.de
About this study
Official title: Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in 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.
- Conditions
- Giant Cell Arteritis
- Being tested
- Analysis of blood and microbiome samples (stool, oral lavage)
- Keywords
- microbiome
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| GCA Patients | Primary diagnosis of giant cell arteritis Receives: Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage) | |
| Control | Control group without rheumatologic disease Receives: Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant differences in the composition of the microbiome
Measured: 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
Measured: At Baseline and 2 year follow up
potential association of microbiome composition with application of immune modulating drugs
Measured: At Baseline and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start29 Feb 2024
- Primary completion18 Feb 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Schäfer, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279065
- Sponsor's protocol ID
- 373/23-EP
- Acronym
- GCA-Biom
- Status last verified
- May 2024
- First submitted
- 15 Feb 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT06279065
- Acronym / sponsor ID
- GCA-Biom / 373/23-EP
- Conditions
- Giant Cell Arteritis
- Keywords
- microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 18 Feb 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCA Patients | – | Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage)Primary diagnosis of giant cell arteritis |
| Control | – | Diagnostic Test: Analysis of blood and microbiome samples (stool, oral lavage)Control group without rheumatologic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- no specific requirements, usually over 50 years
Key inclusion criteria (1 listed)
- Diagnosis of Giant cell arteritis (only in one arm)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Control, GCA Patients |
Primary outcome
Significant differences in the composition of the microbiome
Time frame: At Baseline and 6 month follow up
2 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
Bonn, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University of Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant differences in the composition of the microbiome (time frame: At Baseline and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.