Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis (GCA-Biom)

February 22, 2024 updated by: Valentin Schäfer, University of Bonn
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 (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 commensal will be further analyzed for possible interactions and influence on the immune system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Recruiting
        • Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

no specific requirements, usually over 50 years

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic infection (viral, funghi, bacteria) including HIV, 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)
  • bullimia or anorexia nervosa
  • adipositas (BMI ≥ 40)
  • intake of high dosage of probiotics (>109 KBE 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, CTCL)
  • known abuse of alcohol oder drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GCA Patients
Primary Diagnosis of Giant Cell Arteriitis
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
Control
Control group without rheumatologic disease
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At Baseline and 2 year follow up
potential association of microbiom composition with application of immune modulating drugs
Time Frame: At Baseline and 6 month follow up
At Baseline and 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 18, 2024

Primary Completion (Estimated)

February 18, 2026

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 373/23-EP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Giant Cell Arteritis

Clinical Trials on Analysis of blood and microbiome samples (stool, oral lavage)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe