Health TrialsbyHealthPanel

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

ConditionGiant Cell Arteritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bonn

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

no specific requirements, usually over 50 years

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: GCA Patients1 intervention
Group B: Control1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bonn

Lead sponsor

Source ClinicalTrials.gov
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