Lollipop Swab for Strep Throat
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Wisconsin, Madison
Disqualifiers: Unable to suck, Previous participation, Sugar-free sensitivity
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will enroll children ages 5-17 who test positive for Group A Streptococcus (GAS) at a single clinic visit lasting approximately 30-60 minutes. The primary aim of this study is to assess the accuracy and feasibility of the CandyCollect platform to capture and detect GAS. The investigators hypothesize that the CandyCollect platform is non-inferior to gold-standard rapid antigen detection testing for GAS.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the CandyCollect treatment for diagnosing strep throat?
The CandyCollect device, a lollipop-inspired saliva collection tool, has shown 100% accuracy in detecting bacteria in saliva when compared to traditional methods in healthy adults. Additionally, a study found that using a lollipop-like swab for saliva collection in children with sore throats was nearly as effective as traditional throat swabs for detecting strep throat.
12345Is the Lollipop Swab safe for humans?
There is no specific safety data available for the Lollipop Swab or its related names, but similar products like herbal lollipops have been used in studies without reported safety concerns.
678910How is the CandyCollect treatment for strep throat different from other treatments?
CandyCollect is a unique lollipop-inspired device that collects saliva samples for diagnosing strep throat, offering a more comfortable and user-friendly alternative to traditional throat swabs. It can be used at home and integrates with telemedicine, making it convenient for both children and adults.
123411Eligibility Criteria
This trial is for children aged 5-17 with a sore throat caused by Group A Streptococcus (GAS), confirmed by a rapid test at the clinic. They must be able to understand and complete surveys in English, as should their parents or guardians who consent on their behalf. Children sensitive to sugar-free products or unable to use the CandyCollect swab are excluded.Inclusion Criteria
My child is between 5 and 17 years old.
A positive RADT swab in clinic
I can understand and fill out surveys in English.
+1 more
Exclusion Criteria
I cannot suck on a swab or similar device.
Self-reported sensitivity to sugar-free products
Previous participation in this study
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person)
Sample Collection and Testing
Participants undergo saliva collection using CandyCollect and other methods, followed by surveys to assess experience and preferences
1 day
1 visit (in-person)
Follow-up
Participants are monitored for any immediate reactions and feedback is collected on the testing experience
1 day
1 visit (in-person)
Participant Groups
The study tests the CandyCollect platform's ability to detect GAS from a lollipop-like swab compared to standard rapid antigen testing. It aims to prove that this new, kid-friendly method is just as accurate for diagnosing strep throat during a single clinic visit.
1Treatment groups
Experimental Treatment
Group I: Pediatric Participants with GASExperimental Treatment2 Interventions
Children age 5-17 years old diagnosed via standard Rapid Antigen Detection Test with acute pharyngitis caused by Group A Streptococcus (GAS), along with their parent or legal guardian (aka "caregiver").
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin Hospital and ClinicsMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
National Institutes of Health (NIH)Collaborator
References
CandyCollect: at-home saliva sampling for capture of respiratory pathogens. [2023]Streptococcus pyogenes is a major human-specific bacterial pathogen and a common cause of a wide range of symptoms from mild infection such as pharyngitis (commonly called strep throat) to life-threatening invasive infection and post-infectious sequelae. Traditional methods for diagnosis include collecting a sample using a pharyngeal swab, which can cause discomfort and even discourage adults and children from seeking proper testing and treatment in the clinic. Saliva samples are an alternative to pharyngeal swabs. To improve the testing experience for strep throat, we developed a novel lollipop-inspired sampling platform (called CandyCollect) to capture bacteria in saliva. The device can be used in clinics or in the home and shipped back to a lab for analysis, integrating with telemedicine. CandyCollect is designed to capture bacteria on an oxygen plasma treated polystyrene surface embedded with flavoring substances to enhance the experience for children and inform the required time to complete the sampling process. In addition, the open channel structure prevents the tongue from scraping and removing the captured bacteria. The flavoring substances did not affect bacterial capture and the device has a shelf life of at least 2 months (with experiments ongoing to extend the shelf life). We performed a usability study with 17 participants who provided feedback on the device design and the dissolving time of the candy. This technology and advanced processing techniques, including polymerase chain reaction (PCR), will enable user-friendly and effective diagnosis of streptococcal pharyngitis.
At-Home Saliva Sampling in Healthy Adults Using CandyCollect, a Lollipop-Inspired Device. [2023]Respiratory infections are common in children, and there is a need for user-friendly collection methods. Here, we performed the first human subjects study using the CandyCollect device, a lollipop-inspired saliva collection device .We showed that the CandyCollect device can be used to collect salivary bacteria from healthy adults using Streptococcus mutans and Staphylococcus aureus as proof-of-concept commensal bacteria. We enrolled healthy adults in a nationwide (USA) remote study in which participants were sent study packages containing CandyCollect devices and traditional commercially available oral swabs and spit tubes. Participants sampled themselves at home, completed usability and user preference surveys, and mailed the samples back to our laboratory for analysis by qPCR. Our results showed that for participants in which a given bacterium (S. mutans or S. aureus) was detected in one or both of the commercially available methods (oral swab and/or spit tubes), CandyCollect devices had a 100% concordance with the positive result (n = 14 participants). Furthermore, the CandyCollect device was ranked the highest preference sampling method among the three sampling methods by 26 participants surveyed (combining survey results across two enrollment groups). We also showed that the CandyCollect device has a shelf life of up to 1 year at room temperature, a storage period that is convenient for clinics or patients to keep the CandyCollect device and use it any time. Taken together, we have demonstrated that the CandyCollect is a user-friendly saliva collection tool that has the potential to be incorporated into diagnostic assays in clinic visits and telemedicine.
Detection of Group A Streptococcus in the Saliva of Children Presenting With Pharyngitis Using the cobas Liat PCR System. [2020]Rapid turnaround real-time polymerase chain reaction (PCR) has recently become available as a point-of-care test for group A Streptococcus (GAS) in children presenting with pharyngitis. Our aim in this pilot study was to determine if GAS can be detected in the saliva of children with sore throat using swabs inoculated by children sucking on them as they would a lollipop. Twenty children with positive rapid antigen detection tests for GAS from pharyngeal swabs were enrolled. Pharyngeal and lollipop samples underwent PCR testing using the cobas Liat system. All 20 pharyngeal swabs were positive; 19 of 20 lollipop samples were positive. The increased sensitivity of the new PCR kits for GAS may permit use of less invasive and more comfortable sampling techniques for diagnosis.
At-home saliva sampling in healthy adults using CandyCollect, a lollipop-inspired device. [2023]Respiratory infections are common in children, and there is a need for user-friendly collection methods. Here, we performed the first human subjects study using the CandyCollect device, a lollipop inspired saliva collection device. 1 We showed the CandyCollect device can be used to collect salivary bacteria from healthy adults using Streptococcus mutans and Staphylococcus aureus as proof-of-concept commensal bacteria. We enrolled healthy adults in a nationwide (USA) remote study in which participants were sent study packages containing CandyCollect devices and traditional commercially available oral swabs and spit tubes. Participants sampled themselves at home, completed usability and user preference surveys, and mailed the samples back to our laboratory for analysis by qPCR. Our results showed that for participants in which a given bacterium ( S. mutans or S. aureus ) was detected in one or both of the commercially available methods (oral swab and/or spit tubes), CandyCollect devices had a 100% concordance with the positive result (n=14 participants). Furthermore, the CandyCollect device was ranked the highest preference sampling method among the three sampling methods by 26 participants surveyed (combining survey results across two enrollment groups). We also showed that the CandyCollect device has a shelf life of up to 1 year at room temperature, a storage period that is convenient for clinics or patients to keep the CandyCollect device and use it any time. Taken together, we have demonstrated that the CandyCollect is a user-friendly saliva collection tool that has the potential to be incorporated into diagnostic assays in clinic visits and telemedicine.
Equal performance of self-collected and health care worker-collected pharyngeal swabs for group a streptococcus testing by PCR. [2019]A process employing patient- or parent-collected pharyngeal swabs for group A Streptococcus (GAS) testing would expedite diagnosis and treatment, reduce patient exposure to the health care setting, and decrease health care costs. Our aim was to determine the concordance between patient- or parent-collected (self-collected) and health care worker (HCW)-collected pharyngeal swabs for detection of GAS by PCR. From 9 October 2012 to 21 March 2013, patients presenting with a sore throat meeting criteria for GAS testing and not meeting criteria for severe disease were offered the opportunity to collect their own pharyngeal swab. The HCW also collected a swab. Paired swabs were tested by GAS real-time PCR, allowing semiquantitative comparisons between positive results. Of the 402 participants, 206 had a swab collected by the patient and 196 a swab collected by the parent. The percent positivity results were 33.3% for HCW-collected swabs and 34.3% for self-collected swabs (P = 0.41). The overall concordance between the two collection strategies was 94.0% (95% confidence interval [CI], 91.3 to 96.0). Twenty-four of the paired swabs had discordant results, with 10 and 14 positives detected only with the HCW- and self-collected swabs, respectively (P = 0.41). The person collecting the swab in the self-collected arm, the order of collection, and prior swab collection training did not influence results. Among the 124 specimens that were positive by both collection methods, the amount of GAS DNA was higher in the self-collected versus the HCW-collected swabs (P = 0.008). Self-collected pharyngeal swabs provide a reliable alternative to HCW collection for detection of GAS and offer a strategy for improved health care delivery.
Efficacy of Licorice Lollipops in Reducing Dental Caries in a Paediatric Population: A Systematic Review. [2022]To assess the efficacy of licorice lollipops in reducing dental caries in children.
Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. [2018]The aim of our study was to evaluate the efficacy of an herbal lollipop containing licorice root extract on salivary Streptococcus mutans in caries-free and high-caries-risk children.
Can a licorice lollipop decrease cariogenic bacteria in nursing home residents? [2012]The purpose of this pilot study was to examine whether an herbal lollipop containing licorice root decreases Streptococcus mutans (S. mutans) bacteria that cause dental caries in nursing home residents. A total of 8 residents (5 women, 3 men; mean age = 85) consented to participate in this study. Participants were offered two lollipops per day for 21 days. Saliva samples were collected at baseline and Days 1, 3, 7, 14, and 21, then analyzed for numbers of S. mutans. Using linear mixed-models analysis with difference in numbers of S. mutans from baseline to any time point as the dependent variable, and number of lollipops consumed with effect of time controlled as the predictor variable, participants who consumed more lollipops during the 21-day time period were more likely to have fewer numbers of S. mutans (β = -8.703, p = 0.067). There was a trend toward reduction of S. mutans with consumption of more lollipops during the 21-day period. Recruiting a larger sample for future research may demonstrate a significant reduction.
Comparative Evaluation of Antibacterial Efficacy of Emblica Officinalis Lollipop Against Streptococcus Mutans Counts in Institutionalized Visually Impaired Children. [2022]Background Among the 1.21 billion population of India, 26.8 million individuals have disabilities, and around five million are visually impaired. These children encounter problems related to oral health maintenance, thus further leading to dental problems. Even though Pediatric dentists treat visually impaired children for their oral problems, they emphasize mainly on the prevention of dental caries. Dental caries has a multifactorial etiology, and dentists are unable to find a complete solution for its prevention. However, reducing Streptococcus mutans has been seen to reduce the caries rate in the past. The use of the herbal product Emblica officinalis to reduce Streptococcus mutans levels has been documented. An affordable delivery system is required to use Emblica officinalis for its anticaries action. Thus, a unique delivery system of herbal sugar-free lollipops containing Emblica officinalis extract was made and can effectively deliver antimicrobial action in visually impaired children. Aim To evaluate the antibacterial efficacy of Emblica officinalis lollipop on Streptococcus mutans counts and pH levels in institutionalized visually impaired children. Method A total of 60 institutionalized visually impaired children (age: 4 to 14 years) were selected. The study consisted of two groups (experimental "Emblica officinalis lollipop" and control "placebo lollipop"), and the children were divided equally into both groups. Children from the study and control groups were subjected to the respective lollipops twice daily for seven days. Streptococcus mutans count and pH count were evaluated at baseline and after seven days post-intervention of the respective lollipop. Results The results showed that in both groups, Streptococcus mutans count was reduced post-intervention. However, the efficacy of the study group (Emblica officinalis lollipop) in inhibiting the Streptococcus mutans count was better than the control group (placebo lollipop). An increase in the pH level was seen post-intervention for both the study and control groups. And on the intergroup comparison, no statistical significance was found. Conclusion The use of Emblica officinalis lollipop is effective in inhibiting the Streptococcus mutans count when compared with the placebo lollipop. While marginal pH change was seen in both groups. Thus, the herbal modality most acceptable without any pharmaceutical concerns should be chosen. Emblica officinalis lollipops can be used in institutionalized visually impaired children to reduce the oral Streptococcus mutans count and maintain a healthy oral cavity.
Acidogenic potential of "sugar-free" cough drops. [2021]A patient presented with extensive marginal ditching around restorations recently placed during whole-mouth rehabilitation. The patient was not xerostomic and was otherwise normal except for the self-reported excessive use of "sugar-free" cough drops sweetened with sorbitol and Isomalt® (an equimolar mix of glucosyl-mannitol and glucosylsorbitol). This prompted an in vitro investigation to determine whether Streptococcus sobrinus 6715, a cariogenic streptococcus, could grow and produce acid in growth medium containing an aqueous extract of such "sugar-free" cough drops. The results indicate that S. sobrinus 6715 uses Isomalt® and sorbitol extensively, producing terminal culture pH as low as 4.2 when grown on medium with cough drop extract containing these sugars. This pH is sufficient to demineralize dental enamel. Patients should be cautioned against the chronic overuse of "sugar-free" cough drops and other "sugar-free" confections sweetened with a mixture of Isomalt® and sorbitol.
Usefulness of Leukocyte Esterase Test Versus Rapid Strep Test for Diagnosis of Acute Strep Pharyngitis. [2020]A study to compare the usage of throat swab testing for leukocyte esterase on a test strip(urine dip stick-multi stick) to rapid strep test for rapid diagnosis of Group A Beta hemolytic streptococci in cases of acute pharyngitis in children.