Clinical trial

The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD)

Name
KEK BE 205/13, PB_2016-01922
Description
The primary objective of this study is to assess whether compositional and functional alterations of the gut metagenome may be related to AMD. The primary variable for this assessment is the composition of the gut metagenome which will be analyzed by shotgun sequencing to characterize the faecal metagenome. The secondary endpoint is to assess whether single nucleotide polymorphisms in CFH, ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and APOE genes which have been shown to be risk factors for the development of AMD and other macular diseases correlate with alterations in the gut metagenome .
Trial arms
Trial start
2013-12-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Active (not recruiting)
Treatment
metagenome
metagenome
Arms:
age related macular degeneration, controls
Size
1200
Primary endpoint
taxonomic and functional characterization of gut microbiota
3 years
Eligibility criteria
Inclusion criteria: * Subject must be willing to give written informed consent and willing to provide blood and stool probes * Patients with clinically confirmed AMD 18 years of age or greater * Probands with no signs of AMD 18 years of age or greater Exclusion criteria: * Smoking * Chronic inflammatory disease (autoimmune diseases such as rheumatoid arthritis, lupus erythematodes, chronic inflammatory bowel disease) * Diabetes as defined by The World Health Organization (WHO) criteria * Treated hyperlipidemia * Obesity with a body mass index (BMI) greater than or equal to 30 * Recent (3 month) history of use of systemic antibiotics * Opacities of ocular media excluding detailed observation of the retina
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood serum/ stool'}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

1 product

1 indication

Organization
Insel Gruppe
Product
metagenome