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The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study.

ABSTRACT: Background: The oropharynx plays a major role in the development and spread of antimicrobial resistant Neisseria gonorrhoeae among men who have sex with men. Trials are currently assessing the efficacy of bactericidal mouthwashes as possible therapeutic or preventive options against these pharyngeal gonococcal infections. Controlled clinical trials require the use of a placebo mouthwash without anti-gonococcal activity. So far, no such mouthwash has been described. We describe the development of a mouthwash for this purpose. Methods: The in vitro anti-gonococcal activity of Corsodyl®, Listerine Cool Mint®, Biotene®, phosphate buffered saline and six in-house placebo mouthwashes was evaluated. Three gonococcal isolates from patients with pharyngeal infection were exposed to the mouthwashes for a duration ranging from 30 seconds to 60 minutes. Isolates were then plated onto blood agar (5% horse blood) and incubated for 24 hours (5-7% CO 2, 35 ± 2°C). Growth of N. gonorrhoeae was scored on a five-point scale (0 to 4). All experiments were conducted in duplicate. Results: Corsodyl® and Listerine Cool Mint® were bactericidal to all isolates. For the other mouthwashes, the median growth score after 60 minutes of exposure was 4 (interquartile range 4-4) for phosphate buffered saline; 1 (interquartile range 1-3) for Biotene®; and ranged between 0 and 2 for the in-house composed mouthwashes. An in-house composed mouthwash (Placebo 6) performed best, with a growth score of 2 (interquartile range 2-3). Conclusions: All of the evaluated potential placebo mouthwashes were bacteriostatic after gonococcal exposure of 30 to 60 minutes. In-house composed Placebo 6 showed less inhibition on gonococcal growth than Biotene® and the other in-house placebos and demonstrates, in our opinion, a good trade-off between anti-gonococcal properties and taste.

SUBMITTER: Van Dijck C

PROVIDER: S-EPMC7001748 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study.

Van Dijck Christophe C Cuylaerts Vicky V Sollie Piet P Spychala Anna A De Baetselier Irith I Laumen Jolein J Crucitti Tania T Kenyon Chris C

F1000Research 20190911

<b>Background</b>: The oropharynx plays a major role in the development and spread of antimicrobial resistant <i>Neisseria gonorrhoeae</i> among men who have sex with men. Trials are currently assessing the efficacy of bactericidal mouthwashes as possible therapeutic or preventive options against these pharyngeal gonococcal infections. Controlled clinical trials require the use of a placebo mouthwash without anti-gonococcal activity. So far, no such mouthwash has been described. We describe the ...[more]

PMID: 32089824

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Project description:BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17589.

Dataset Information

The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study.

Publications

The development of mouthwashes without anti-gonococcal activity for controlled clinical trials: an in vitro study.

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