Deciphering the Impact of Exposures From the Gut Microbiome-derived Molecular Complex in Human Health and Disease

Status: Completed
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The ExpoBiome project will analyze the impact of fasting on patients with Parkinsons's Disease (PD) or rheumatoid arthritis (RA) on a clinical level as well as the effect of fasting on their immune system and gut microbiota. ExpoBiome will combine metagenomics and other omics \[meta-transcriptomics, meta-proteomics and (meta-)metabolomics\], bioinformatic analyses and biostatistics under a systems biology framework to gain new mechanistic insights into microbiome-immune system interactions in the context of chronic diseases with inflammatory signatures. Besides a one time crossectional study of healthy participants, patients with RA and PD a longitudinal fasting study with two arms (RA and PD) is planned.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: t
View:

• One of the following diagnoses: rheumatoid arthritis (first diagnosis \>6 weeks ago and \<8 years), parkinson's disease OR healthy volunteer

• Control (healthy) individuals must be without any evidence of active, known or treated RA, without any evidence of active, known or treated central nervous system disease, and without a known family history of idiopathic PD

• Arthritis in at least one joint

• Control individuals should match the RA or PD individuals as closely as possible, especially their age, sex, and education

• Present written declaration of consent

• Consent to specimen collection and specimen use

• Ability to understand the patient information and willingness to sign the consent form

Locations
Other Locations
Germany
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin
Paracelsus-Elena-Klinik Kassel
Kassel
Time Frame
Start Date: 2021-04-21
Completion Date: 2023-09-26
Participants
Target number of participants: 183
Treatments
Experimental: RA - longitudinal arm
Experimental: PD - longitudinal arm
No_intervention: RA - crosssectional arm
No_intervention: PD - crossectional arm
No_intervention: Healthy controls - crosssectional arm
Sponsors
Collaborators: University of Luxembourg, Paracelsus Elena Klinik
Leads: Andreas Michalsen

This content was sourced from clinicaltrials.gov