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Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial

BACKGROUND: Ocular rosacea is common and is often managed with long-term antibiotic treatment. Doxycycline is the most commonly selected antibiotic for the treatment of rosacea. As there is no established standard of care treatment dose for rosacea, prescribed doses of doxycycline vary widely. The F...

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Autores principales: Mahmud, Hamidah, Keenan, Jeremy D., Gonzales, John, Schallhorn, Julie, Chan, Matilda, Arnold, Benjamin, Cavallino, Victoria, Lietman, Thomas M., Doan, Thuy, Seitzman, Gerami D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769060/
https://www.ncbi.nlm.nih.gov/pubmed/36539810
http://dx.doi.org/10.1186/s13063-022-06948-9
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author Mahmud, Hamidah
Keenan, Jeremy D.
Gonzales, John
Schallhorn, Julie
Chan, Matilda
Arnold, Benjamin
Cavallino, Victoria
Lietman, Thomas M.
Doan, Thuy
Seitzman, Gerami D.
author_facet Mahmud, Hamidah
Keenan, Jeremy D.
Gonzales, John
Schallhorn, Julie
Chan, Matilda
Arnold, Benjamin
Cavallino, Victoria
Lietman, Thomas M.
Doan, Thuy
Seitzman, Gerami D.
author_sort Mahmud, Hamidah
collection PubMed
description BACKGROUND: Ocular rosacea is common and is often managed with long-term antibiotic treatment. Doxycycline is the most commonly selected antibiotic for the treatment of rosacea. As there is no established standard of care treatment dose for rosacea, prescribed doses of doxycycline vary widely. The FDA classifies 40 mg daily dose of doxycycline for ocular rosacea as sub-microbial in comparison to an antibiotic dose of 200 mg daily. However, this “sub-microbial” dose has never been evaluated in patients with ocular rosacea, and even the sub-microbial dose has potential to alter systemic mucosa flora. Here, we present a randomized controlled trial using RNA sequencing to fully characterize the impact of sub-microbial antibiotic dosing of doxycycline on antimicrobial resistance and bacterial composition of the ocular and gut flora. METHODS: In a triple-masked parallel randomized control trial, patients with ocular rosacea will be randomized to three arms: a 40-mg dose of doxycycline, a 200-mg antibiotic dose of doxycycline, or placebo. Collected rectal and lower eyelid samples will be compared for frequency of antimicrobial resistance genetic determinants and microbiome diversity. A subjective ocular surface disease index survey and objective tear breakup time measurement will be determined. DISCUSSION: These results will enhance our understanding of the overall systemic impact of long-term systemic sub-microbial antibiotic dosing for the treatment of chronic recurrent ocular inflammatory diseases. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.org (NCT05296837) on March 22, 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06948-9.
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spelling pubmed-97690602022-12-22 Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial Mahmud, Hamidah Keenan, Jeremy D. Gonzales, John Schallhorn, Julie Chan, Matilda Arnold, Benjamin Cavallino, Victoria Lietman, Thomas M. Doan, Thuy Seitzman, Gerami D. Trials Study Protocol BACKGROUND: Ocular rosacea is common and is often managed with long-term antibiotic treatment. Doxycycline is the most commonly selected antibiotic for the treatment of rosacea. As there is no established standard of care treatment dose for rosacea, prescribed doses of doxycycline vary widely. The FDA classifies 40 mg daily dose of doxycycline for ocular rosacea as sub-microbial in comparison to an antibiotic dose of 200 mg daily. However, this “sub-microbial” dose has never been evaluated in patients with ocular rosacea, and even the sub-microbial dose has potential to alter systemic mucosa flora. Here, we present a randomized controlled trial using RNA sequencing to fully characterize the impact of sub-microbial antibiotic dosing of doxycycline on antimicrobial resistance and bacterial composition of the ocular and gut flora. METHODS: In a triple-masked parallel randomized control trial, patients with ocular rosacea will be randomized to three arms: a 40-mg dose of doxycycline, a 200-mg antibiotic dose of doxycycline, or placebo. Collected rectal and lower eyelid samples will be compared for frequency of antimicrobial resistance genetic determinants and microbiome diversity. A subjective ocular surface disease index survey and objective tear breakup time measurement will be determined. DISCUSSION: These results will enhance our understanding of the overall systemic impact of long-term systemic sub-microbial antibiotic dosing for the treatment of chronic recurrent ocular inflammatory diseases. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.org (NCT05296837) on March 22, 2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06948-9. BioMed Central 2022-12-20 /pmc/articles/PMC9769060/ /pubmed/36539810 http://dx.doi.org/10.1186/s13063-022-06948-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Mahmud, Hamidah
Keenan, Jeremy D.
Gonzales, John
Schallhorn, Julie
Chan, Matilda
Arnold, Benjamin
Cavallino, Victoria
Lietman, Thomas M.
Doan, Thuy
Seitzman, Gerami D.
Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title_full Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title_fullStr Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title_full_unstemmed Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title_short Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
title_sort ocular rosacea microbiome study (orbs)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9769060/
https://www.ncbi.nlm.nih.gov/pubmed/36539810
http://dx.doi.org/10.1186/s13063-022-06948-9
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