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

NCT04847011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2024-01-29

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Fasting

Patients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al.

Sponsors & Collaborators

  • University of Luxembourg

    collaborator OTHER

  • Paracelsus Elena Klinik

    collaborator OTHER

  • Andreas Michalsen

    lead OTHER

Principal Investigators

  • Andreas Michalsen, Prof. Dr. med. · Charite - Universitätsmedizin Berlin

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2023-09-26
Completion
2023-09-26

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847011 on ClinicalTrials.gov