#SWISH AND SWALLOW FOR THRUSH TRIAL#

Effects of probiotics, prebiotics, and synbiotics on human health. Denture cleanliness and hygiene: an overview. Health benefits of heat-killed (tyndallized) probiotics: An overview. Presence of oral warts during the screening period or at the study entry visit before, Institute for Quality and Efficiency in Health Care (IQWiG).Previous or current history of porphyria.Hospitalization within 30 days prior to study entry for HIV or HIV-related conditions.Serious illness, in the opinion of the site investigator, requiring systemic treatment.Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.Intend to use any additional oral topical treatments within the study- defined 14-day treatment period.Intend to initiate ART during the screening period, at study entry, or within the study-defined 14-day treatment period.Anticipated need for systemic or oral/topical antifungal agents for other diagnoses within the study-defined 14-day treatment period.Use of any antifungal agents within 30 days prior to study entry.Use of inhaled or systemic corticosteroids within 14 days prior to study entry.Concurrent vaginal candidiasis within 21 days prior to study entry.NOTE: For purposes of this study, drugs available under an FDA-authorized expanded access program was NOT considered investigational. Use of any investigational drug currently or within 30 days prior to study entry.Documented or presumptive signs or symptoms of esophageal candidiasis (e.g., dysphagia) during the screening period unless endoscopic examination of the esophagus was performed, and fungal esophagitis were excluded.CD4+ cell count obtained within 30 days prior to study entry at a DAIDS-approved laboratory.NOTE: Participants who were not ART-naïve and not on ART were eligible to participate in the study if they did not intend to initiate ART during the study- defined 14-day treatment period. If on an antiretroviral therapy (ART), initiation of regimen at least 12 weeks prior to study entry, and willingness of participant to remain on current ART regimen until the study-defined 14-day treatment period was complete.Participants with documented angular chelitis and/or erythematous candidiasis without pseudomembranous candidiasis were not eligible to enroll in the study. Pseudomembranous candidiasis documented by a complete oral exam (i.e., white or yellow spots or plaques with an underlying erythematous base, located in any part of the oral cavity) at the screening visit.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled and participants are expected to be on the study for about 13 weeks. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days.

#SWISH AND SWALLOW FOR THRUSH TRIAL#

Why Should I Register and Submit Results?Ī5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension.

Swish and swallow for thrush