The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD)
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| ClinicalTrials.gov Identifier: NCT02438111 |
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Recruitment Status :
Active, not recruiting
First Posted : May 8, 2015
Last Update Posted : December 1, 2022
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Sponsor:
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
| Tracking Information | ||||||||||
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| First Submitted Date | April 28, 2015 | |||||||||
| First Posted Date | May 8, 2015 | |||||||||
| Last Update Posted Date | December 1, 2022 | |||||||||
| Study Start Date | December 2013 | |||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
taxonomic and functional characterization of gut microbiota [ Time Frame: 3 years ] | |||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD) | |||||||||
| Official Title | The Role of the Gut Metagenome on the Development of Age Related Macular Degeneration (AMD) | |||||||||
| 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 . | |||||||||
| 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 Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: blood serum/ stool
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| Sampling Method | Probability Sample | |||||||||
| Study Population | Patients with age related macular degeneration (AMD) | |||||||||
| Condition | Age Related Macular Degeneration | |||||||||
| Intervention | Genetic: metagenome
metagenome
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Active, not recruiting | |||||||||
| Estimated Enrollment |
1200 | |||||||||
| Original Estimated Enrollment |
200 | |||||||||
| Estimated Study Completion Date | December 2023 | |||||||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion criteria:
Exclusion criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Switzerland | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT02438111 | |||||||||
| Other Study ID Numbers | KEK BE 205/13, PB_2016-01922 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | University Hospital Inselspital, Berne | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | University Hospital Inselspital, Berne | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | University Hospital Inselspital, Berne | |||||||||
| Verification Date | November 2022 | |||||||||