Status:
COMPLETED
Deciphering the Impact of Exposures From the Gut Microbiome-derived Molecular Complex in Human Health and Disease
Lead Sponsor:
Andreas Michalsen
Collaborating Sponsors:
University of Luxembourg
Paracelsus Elena Klinik
Conditions:
Rheumatoid Arthritis
Parkinson Disease
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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 sy...
Detailed Description
The human gut microbiome is a complex ecosystem, which contributes essential functions to human physiology. Changes to the microbiome are associated with several chronic diseases characterised by infl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- gout or proven bacterial arthritis
- Psychiatric illness that limits understanding of the examination protocol (unable to consent)
- BMI \< 18.5
- Pre-existing/current eating disorders (bulimia nervosa, anorexia nervosa) within the past 5 years.
- Severe internal diseases (e.g. renal insufficiency with creatinine \> 2mg/dl)
- Participation in another study
- Existing vegan diet or fasting within the past 6 months
- Pregnancy or breastfeeding
- Chronic inflammatory bowel disease
- Use of antibiotics within the past 12 months
- Presence of anemia
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT04847011
Start Date
April 21 2021
End Date
September 26 2023
Last Update
January 29 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Paracelsus-Elena-Klinik Kassel
Kassel, Hesse, Germany, 34128
2
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, Germany, 14109