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NCT04847011: ExpoBiome
Deciphering the Impact of Exposures From the Gut Microbiome-derived Molecular Complex in Human Health and Disease
NA trial testing Fasting in Rheumatoid Arthritis in 183 participants. Completed in 26 September 2023.
26 September 2023
Quick facts
| Lead sponsor | Andreas Michalsen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 183 |
| Start date | 21 April 2021 |
| Primary completion | 26 September 2023 |
| Estimated completion | 26 September 2023 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- Fasting
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Parkinson Disease — all drugs for Parkinson Disease →
- Healthy — all drugs for Healthy →
Sponsor
Andreas Michalsen
Who can join
Adults 18 to 79, any sex, with Rheumatoid Arthritis or Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Dietary Interventions in Parkinson's Disease.
van der Berg I, Schootemeijer S, Overbeek K, Bloem BR, et al · · 2024 · cited 18× · PMID 38277304 · DOI 10.3233/jpd-230366 -
Protocol for a multicentre cross-sectional, longitudinal ambulatory clinical trial in rheumatoid arthritis and Parkinson's disease patients analysing the relation between the gut microbiome, fasting and immune status in Germany (ExpoBiome).
Hansen B, Laczny CC, Aho VTE, Frachet-Bour A, et al · · 2023 · cited 7× · PMID 37597865 · DOI 10.1136/bmjopen-2022-071380 -
Lifestyle Interventions and Innovative Approaches for the Management of Neurodegenerative Disorders in Older Adults-State-Of-The-Art and Future Directions.
Popescu I, Lenain M, Rovini E, Ruthsatz M. · · 2025 · cited 2× · PMID 40161281 · DOI 10.1177/15598276251330170 -
Immunophenotyping of Patients With Rheumatoid Arthritis Reveals Difference in CD27<sup>+</sup>IgD<sup>+</sup> Unswitched Memory B Cell Profiles.
Hansen B, Da Costa R, Revets D, Hedin F, et al · · 2025 · PMID 40766288 · DOI 10.1155/mi/9675331 -
Fasting-driven suppression of disease activity in rheumatoid arthritis
Hansen B, Villette R, Petrov V, Laczny CC, et al · · 2025 · DOI 10.21203/rs.3.rs-6904467/v1
Verify or expand the search:
- PubMed search for NCT04847011
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fasting
Trials testing the same drug.
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- NCT06826924 — 7-Days Water-Only Fasting Trial in Prostate Cancer · NA · recruiting
- NCT07009288 — A Study of Time-Restricted Eating in Childhood Cancer Survivors · NA · recruiting
- NCT06963437 — Interventions for Weight Regain After Bariatric Surgery · NA · completed
- NCT07178106 — Investigation of the Relationship Between Peripheral and Central Metabolic Changes Caused by Fasting · NA · completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04847011 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Andreas Michalsen
- Last refreshed: 29 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04847011.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing