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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02438111
Other study ID # KEK BE 205/13, PB_2016-01922
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2013
Est. completion date December 2023

Study information

Verified date April 2023
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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 .


Description:

Age-related macular degeneration (AMD) is the most frequent cause of blindness in the elderly. Despite major research efforts in the last decades the etiology of AMD remains largely undefined and therefore treatment options are only very limited. However, there is evidence that nutrition and inflammation play a role in the pathogenesis of AMD . The latter is also corroborated by the finding that single nucleotide polymorphism in the gene encoding complement factor H is associated with AMD . In addition to CHF other genes such as ARMS2, C3, PLEKHA1, HTRA-1, VEGF-A, VEGF-B, VEGFR and APOE have been associated with development of AMD. Recent findings have implicated the gut microbiota as a contributor of metabolic diseases through the modulation of host metabolism and inflammation . Gut bacteria use mostly fermentation to generate energy, converting sugars, in part, to short-chain fatty acid, that are used by the host as energy source. Beyond short-chain fatty acids gut bacteria can provide some amino acids and contribute certain vitamins such as biotin to the host . The investigators propose to investigate whether compositional and functional alterations of the gut microbiota are a risk factor for developing AMD.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1200
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
metagenome
metagenome

Locations

Country Name City State
Switzerland Inselspital Bern, Department of Ophthalmology Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary taxonomic and functional characterization of gut microbiota 3 years
Secondary Gut-microbiota-based AMD classification 3 years
Secondary AMD-associated gut microbial markers 3 years
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