|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
1 May 2023 |
|
Main ID: |
NCT02438111 |
|
Date of registration:
|
28/04/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD)
|
|
Scientific title:
|
The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD) |
|
Date of first enrolment:
|
December 2013 |
|
Target sample size:
|
1200 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02438111 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Martin S Zinkernagel, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Ophthalmology, University Hospital Bern, Switzerland |
|
|
Name:
|
Martin Zinkernagel, M.D, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Ophthalmology, University Hospital Bern, Switzerland |
|
|
Name:
|
Martin Fiedler, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital Bern, Switzerland |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Age Related Macular Degeneration
|
|
Intervention(s)
|
|
Genetic: metagenome
|
|
Primary Outcome(s)
|
|
taxonomic and functional characterization of gut microbiota
[Time Frame: 3 years]
|
|
Secondary Outcome(s)
|
|
AMD-associated gut microbial markers
[Time Frame: 3 years]
|
|
Gut-microbiota-based AMD classification
[Time Frame: 3 years]
|
|
Secondary ID(s)
|
|
KEK BE 205/13, PB_2016-01922
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|