ClinicalTrials.gg
RecruitingNCT06279065GCA-BiomUpdated May 9, 2024

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

An observational study in Giant Cell Arteritis, sponsored by University of Bonn. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University of Bonn · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Giant Cell Arteritis

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Keywords

  • microbiome
03

In context

Giant Cell Arteritis

147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.

This study's planned enrollment of 50 is below the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

University of Bonn is the lead sponsor of 39 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

no specific requirements, usually over 50 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, /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 ( ≥ 40)
  • intake of high dosage of probiotics (>10\^9 colony forming units per day) \<90 days before screening
  • not controlled Diabetes mellitus
  • within one year (except for squamous skin - and basal skin carcinoma without , cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)
  • known abuse of alcohol oder drugs.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

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What researchers measure

Primary outcomes

  1. Significant differences in the composition of the microbiome

    Time frame: At Baseline and 6 month follow up

Secondary outcomes

  1. 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

  2. potential association of microbiome composition with application of immune modulating drugs

    Time frame: At Baseline and 6 month follow up

07

Study locations

2 of 2 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06279065
Lead sponsor
University of Bonn
Responsible party
Valentin Schäfer (Head of the rheumatology department, University Hospital Bonn, University of Bonn) — Principal investigator
First posted
Feb 26, 2024
Start date
Feb 29, 2024
Primary completion
Feb 18, 2026 (estimated)
Completion
Feb 2028 (estimated)
Last update
May 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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