Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438111
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 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 : November 2020
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
age related macular degeneration
metagenome AMD
Genetic: metagenome
metagenome

controls
metagenome controls
Genetic: metagenome
metagenome




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 (Alberti and Zimmet 1998)
  • 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

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


Contacts
Layout table for location contacts
Contact: Martin S Zinkernagel, MD, PhD +41316329565 martin.zinkernagel@insel.ch
Contact: Sebastian Wolf, MD, PhD +41316329565 sebastian.wolf@insel.ch

Locations
Layout table for location information
Switzerland
Inselspital Bern, Department of Ophthalmology Recruiting
Bern, Switzerland, 3010
Contact: Martin Zinkernagel, MD, PhD    +41316329565    martin.zinkernagel@insel.ch   
Contact: Corinne Stöckli    +41316321197    corinne.stöckli@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Layout table for investigator information
Study Chair: Sebastian Wolf, 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
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02438111    
Other Study ID Numbers: KEK BE 205/13
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases