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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438111
Recruitment Status : Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : December 1, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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Brief 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 .

Condition or disease Intervention/treatment
Age Related Macular Degeneration Genetic: metagenome

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD)
Study Start Date : December 2013
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
age related macular degeneration
metagenome AMD
 Genetic: metagenome
metagenome
controls
metagenome controls
 Genetic: metagenome
metagenome


Outcome Measures
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Primary Outcome Measures :
  1. taxonomic and functional characterization of gut microbiota [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Gut-microbiota-based AMD classification [ Time Frame: 3 years ]
  2. AMD-associated gut microbial markers [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
blood serum/ stool

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with age related macular degeneration (AMD)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438111


Locations
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Switzerland
Inselspital Bern, Department of Ophthalmology
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Martin Zinkernagel, M.D, PhD Department of Ophthalmology, University Hospital Bern, Switzerland
Principal Investigator: Martin S Zinkernagel, MD, PhD Department of Ophthalmology, University Hospital Bern, Switzerland
Study Director: Martin Fiedler, MD University Hospital Bern, Switzerland
More Information
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02438111    
Other Study ID Numbers: KEK BE 205/13, PB_2016-01922
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases