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

NCT04847011 | Completed

• 1 other identifier: ExpoBiome
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 2

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 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

Rheumatoid Arthritis; Parkinson Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Gut microbiota Characterization

  Molecular typing of the gut microbiota using sequencing and high-throughput analysis from stool samples (metagenomics, metatranscriptomics, metaproteomics, metabolomics)

  Change over baseline to 12 months

Secondary Outcomes (48)

• Resting blood pressure

  Change over baseline to 12 months

• Heart rate

  Change over baseline to 12 months

• Abdominal circumference

  Change over baseline to 12 months

• Waist to Hip Ratio

  Change over baseline to 12 months

• Body Mass Index (kg/m2)

  Change over baseline to 12 months

Study Arms (5)

RA - longitudinal arm

EXPERIMENTAL

Other: Fasting

PD - longitudinal arm

EXPERIMENTAL

Other: Fasting

RA - crosssectional arm

NO INTERVENTION

PD - crossectional arm

NO INTERVENTION

Healthy controls - crosssectional arm

NO INTERVENTION

Interventions

Fasting OTHER

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.

PD - longitudinal arm; RA - longitudinal arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andreas Michalsen: lead
• University of Luxembourg: collaborator
• Paracelsus Elena Klinik: collaborator

Study Sites (2)

Paracelsus-Elena-Klinik Kassel

Kassel, Hesse, 34128, Germany

Location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Location

Related Publications (1)

• Hansen B, Laczny CC, Aho VTE, Frachet-Bour A, Habier J, Ostaszewski M, Michalsen A, Hanslian E, Koppold DA, Hartmann AM, Steckhan N, Mollenhauer B, Schade S, Roomp K, Schneider JG, Wilmes P. 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). BMJ Open. 2023 Aug 18;13(8):e071380. doi: 10.1136/bmjopen-2022-071380.

  PMID: 37597865 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Parkinson Disease

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Andreas Michalsen, Prof. Dr. med.

  Charite - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 15, 2021
• Study Start: April 21, 2021
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

DE (2)