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
Abstract 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 widel...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-12-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06948-9 |
| _version_ | 1797977293827604480 |
|---|---|
| author | Hamidah Mahmud Jeremy D. Keenan John Gonzales Julie Schallhorn Matilda Chan Benjamin Arnold Victoria Cavallino Thomas M. Lietman Thuy Doan Gerami D. Seitzman |
| author_facet | Hamidah Mahmud Jeremy D. Keenan John Gonzales Julie Schallhorn Matilda Chan Benjamin Arnold Victoria Cavallino Thomas M. Lietman Thuy Doan Gerami D. Seitzman |
| author_sort | Hamidah Mahmud |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-11T05:04:35Z |
| format | Article |
| id | doaj.art-c5423f402bd9433b9797546fc38482e0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T05:04:35Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c5423f402bd9433b9797546fc38482e02022-12-25T12:28:25ZengBMCTrials1745-62152022-12-012311910.1186/s13063-022-06948-9Ocular 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 trialHamidah Mahmud0Jeremy D. Keenan1John Gonzales2Julie Schallhorn3Matilda Chan4Benjamin Arnold5Victoria Cavallino6Thomas M. Lietman7Thuy Doan8Gerami D. Seitzman9San Francisco School of Medicine, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaFrancis I. Proctor Foundation, University of CaliforniaAbstract 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.https://doi.org/10.1186/s13063-022-06948-9Ocular rosaceaMicrobiomeDoxycyclineSub-microbialAntimicrobial resistance |
| spellingShingle | Hamidah Mahmud Jeremy D. Keenan John Gonzales Julie Schallhorn Matilda Chan Benjamin Arnold Victoria Cavallino Thomas M. Lietman Thuy Doan Gerami D. Seitzman 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 Trials Ocular rosacea Microbiome Doxycycline Sub-microbial Antimicrobial resistance |
| 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 | Ocular rosacea Microbiome Doxycycline Sub-microbial Antimicrobial resistance |
| url | https://doi.org/10.1186/s13063-022-06948-9 |
| work_keys_str_mv | AT hamidahmahmud ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT jeremydkeenan ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT johngonzales ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT julieschallhorn ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT matildachan ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT benjaminarnold ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT victoriacavallino ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT thomasmlietman ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT thuydoan ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial AT geramidseitzman ocularrosaceamicrobiomestudyorbssubmicrobialversusantibioticdosingofdoxycyclineversusplacebointreatmentofsymptomaticocularrosaceastudyprotocolforaparallelarmrandomizedclinicaltrial |