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Associations Between the Oral and Intestinal Icrobiome and Neovascular Age-related Macular Degeneration

Primary Purpose

Neovascular Age-related Macular Degeneration

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Probiotic Combination Cap/Tab
intravitreal Anti-VEGF injection
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neovascular Age-related Macular Degeneration focused on measuring neovascular AMD, microbiome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Normal BMI patients Diagnosed as neovascular AMD (experimental & sham group) Normal patients (control group) Exclusion Criteria: Obese (BMI > 30) Past surgical history involving intestinal diseases Previous oral antibiotic treatment before 1 week at the baseline enroll Previous oral probiotics supplement Previous ophthalmic retinal diseases except neovascular AMD

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement

neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement

Control patients, no oral probiotics supplement

Arm Description

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. Oral probiotics (The Perfect Probiotics®) supplement will be given to the participants for 6 months.

Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.

Healthy, no retinal disease patients will be allocated. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.

Outcomes

Primary Outcome Measures

Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
The investigators will analyze the oral microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.
Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients
The investigators will analyze the intestinal microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.

Secondary Outcome Measures

Visual acuity changes after oral probiotics supplement
If possible, visual acuity difference between experimental and sham group (oral probiotics vs. no oral probiotics) in the neovascular AMD patients. Visual acuity will be measured by the ETDRS eye chart (scale : letters).

Full Information

First Posted
October 17, 2022
Last Updated
August 21, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05604989
Brief Title
Associations Between the Oral and Intestinal Icrobiome and Neovascular Age-related Macular Degeneration
Official Title
Associations Between the Oral and Intestinal Microbiome and Neovascular Age-related Macular Degeneration and the Investigation on the Effect of Oral Probiotics as a Treatment - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot study for Associations between the oral and intestinal microbiome and neovascular age-related macular degeneration and the investigation on the effect of oral probiotics as a treatment The investigators recruit the neovascular AMD patients and control patients. 15 neovascular AMD patients with anti-VEGF treatment and oral probiotics supplement 15 neovascular AMD patients with anti-VEGF treatment and no oral probiotics supplement 15 control patients and no oral probiotics supplement The investigators will collect stool, blood, and saliva sample at the baseline and 6 months, and analyze the oral and intestinal microbiome changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
neovascular AMD, microbiome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neovascular AMD patients with anti-VEGF treatment, oral probiotics supplement
Arm Type
Experimental
Arm Description
Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. Oral probiotics (The Perfect Probiotics®) supplement will be given to the participants for 6 months.
Arm Title
neovascular AMD patients with anti-VEGF treatment, no oral probiotics supplement
Arm Type
Sham Comparator
Arm Description
Neovascular AMD patients will be allocated. Regular intravitreal anti-VEGF injection treatment will be done. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.
Arm Title
Control patients, no oral probiotics supplement
Arm Type
No Intervention
Arm Description
Healthy, no retinal disease patients will be allocated. At the baseline and 6 months, the investigators will collect stool, saliva, and blood samples for microbiome analysis. No Oral probiotics (The Perfect Probiotics®) supplement in this group.
Intervention Type
Drug
Intervention Name(s)
Probiotic Combination Cap/Tab
Other Intervention Name(s)
The Perfect Probiotics®
Intervention Description
The Perfect Probiotics® capsule will be given as an intervention, which is composed of mostly Lactobacillus acidophilus & Bifidobacterium lactis.
Intervention Type
Drug
Intervention Name(s)
intravitreal Anti-VEGF injection
Intervention Description
Intravitreal anti-VEGF injection treatment in the neovascular AMD patients.
Primary Outcome Measure Information:
Title
Oral microbiome changes after oral probiotics supplement in neovascular AMD patients
Description
The investigators will analyze the oral microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.
Time Frame
6 months after enrollment
Title
Intestinal microbiome changes after oral probiotics supplement in neovascular AMD patients
Description
The investigators will analyze the intestinal microbiome changes (baseline and 6 months after taking oral probiotics) in experimental, sham, and control groups. Microbiome relative abundance changes in percentage (%) will be statistically analyzed between baseline and 6 months.
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Visual acuity changes after oral probiotics supplement
Description
If possible, visual acuity difference between experimental and sham group (oral probiotics vs. no oral probiotics) in the neovascular AMD patients. Visual acuity will be measured by the ETDRS eye chart (scale : letters).
Time Frame
6 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal BMI patients Diagnosed as neovascular AMD (experimental & sham group) Normal patients (control group) Exclusion Criteria: Obese (BMI > 30) Past surgical history involving intestinal diseases Previous oral antibiotic treatment before 1 week at the baseline enroll Previous oral probiotics supplement Previous ophthalmic retinal diseases except neovascular AMD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwangsic Joo, MD PhD
Phone
82-31-787-7387
Email
namooj@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwangsic Joo, MD PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwangsic Joo, MD PhD
Phone
82-31-787-7387
Email
namooj@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Associations Between the Oral and Intestinal Icrobiome and Neovascular Age-related Macular Degeneration

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