Lollipop Swab for Strep Throat

Overseen By Elena Alfaro

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Unable to suck, Previous participation, Sugar-free sensitivity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

210 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{1 2 3 4 11}

Research Team

Gregory DeMuri, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility 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.

Exclusion Criteria

I cannot suck on a swab or similar device.

Self-reported sensitivity to sugar-free products

Previous participation in this study

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)

Treatment Details

Interventions

• CandyCollect
• Lollipop Swab
• LolliTest

Trial Overview 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.

Participant Groups

Group I: Pediatric Participants with GAS Experimental Treatment 2 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").

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

The CandyCollect device, a lollipop-inspired sampling platform, offers a more comfortable and user-friendly alternative to traditional pharyngeal swabs for diagnosing strep throat, making it suitable for both clinics and home use.

In a usability study with 17 participants, the device effectively captured bacteria without affecting the flavoring, ensuring a pleasant experience while maintaining diagnostic accuracy through advanced techniques like PCR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CandyCollect: at-home saliva sampling for capture of respiratory pathogens. Lee, UN., Su, X., Hieber, DL., et al.[2023]

The CandyCollect device, a lollipop-inspired saliva collection tool, demonstrated 100% accuracy in detecting salivary bacteria (Streptococcus mutans and Staphylococcus aureus) when compared to traditional methods in a study involving healthy adults.

Participants preferred the CandyCollect device over traditional oral swabs and spit tubes, indicating its potential for user-friendly application in clinical diagnostics and telemedicine, with a shelf life of up to 1 year at room temperature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-Home Saliva Sampling in Healthy Adults Using CandyCollect, a Lollipop-Inspired Device. Tu, WC., McManamen, AM., Su, X., et al.[2023]

A pilot study involving 20 children with sore throats showed that saliva samples collected from lollipop-style swabs detected group A Streptococcus (GAS) in 19 out of 20 cases, demonstrating a high level of accuracy.

The use of rapid PCR testing for GAS in saliva could provide a less invasive and more comfortable alternative to traditional pharyngeal swabs, potentially improving the diagnosis process for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Group A Streptococcus in the Saliva of Children Presenting With Pharyngitis Using the cobas Liat PCR System. DeMuri, G., Wald, ER.[2020]

The CandyCollect device, a lollipop-inspired saliva collection tool, successfully collected salivary bacteria from healthy adults, showing 100% concordance with traditional methods for detecting Streptococcus mutans and Staphylococcus aureus in a study of 14 participants.

Participants preferred the CandyCollect device over traditional sampling methods, and it has a shelf life of up to 1 year at room temperature, making it a convenient option for both clinics and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-home saliva sampling in healthy adults using CandyCollect, a lollipop-inspired device. Tu, WC., McManamen, AM., Su, X., et al.[2023]

Self-collected pharyngeal swabs for group A Streptococcus (GAS) testing showed a high concordance rate of 94% compared to health care worker (HCW)-collected swabs, indicating that patients or parents can reliably collect samples for testing.

The study involved 402 participants and found that self-collected swabs not only matched HCW results in terms of positivity rates (34.3% vs. 33.3%) but also had a higher amount of GAS DNA detected, suggesting they could be a more effective method for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Equal performance of self-collected and health care worker-collected pharyngeal swabs for group a streptococcus testing by PCR. Murray, MA., Schulz, LA., Furst, JW., et al.[2019]

Licorice lollipops have shown a promising effect in reducing dental caries in children by lowering the levels of Streptococcus mutans in saliva, which is a key bacteria involved in tooth decay.

The review included only three studies, with one being of high quality, indicating a need for more rigorous research, particularly randomized controlled trials with larger sample sizes to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Licorice Lollipops in Reducing Dental Caries in a Paediatric Population: A Systematic Review. Nuvvula, S., Nunna, M., Almaz, ME., et al.[2022]

In a study involving 108 children aged 5-11, herbal lollipops containing licorice root extract significantly reduced salivary levels of Streptococcus mutans in high-caries-risk children who did not comply with dental treatment.

The results suggest that these herbal lollipops could be a beneficial alternative to high-carbohydrate snacks for high-caries-risk children, promoting better oral health by lowering harmful bacteria levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Almaz, ME., Sönmez, IŞ., Ökte, Z., et al.[2018]

In a pilot study involving 8 nursing home residents, consuming herbal lollipops containing licorice root showed a trend toward reducing the levels of Streptococcus mutans, the bacteria responsible for dental caries.

Participants who consumed more lollipops over the 21-day period tended to have lower numbers of S. mutans, suggesting that larger studies could confirm the efficacy of this herbal intervention in improving oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a licorice lollipop decrease cariogenic bacteria in nursing home residents? Mentes, JC., Kang, S., Spackman, S., et al.[2012]

A study involving 60 visually impaired children showed that lollipops containing Emblica officinalis effectively reduced the levels of Streptococcus mutans, a bacteria linked to dental caries, compared to a placebo lollipop.

Both the Emblica officinalis lollipop and the placebo led to an increase in pH levels in the mouth, but the study group demonstrated a significantly better reduction in harmful bacteria, suggesting that these herbal lollipops could be a safe and effective oral health intervention for visually impaired children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Antibacterial Efficacy of Emblica Officinalis Lollipop Against Streptococcus Mutans Counts in Institutionalized Visually Impaired Children. Bane, SP., Thosar, NR., Rathi, NV., et al.[2022]

An in vitro study showed that the cariogenic bacteria Streptococcus sobrinus can thrive and produce acid when exposed to 'sugar-free' cough drops sweetened with Isomalt® and sorbitol, leading to a dangerously low pH of 4.2.

This acidic environment is capable of demineralizing dental enamel, suggesting that excessive use of these cough drops can contribute to dental decay, and patients should be warned about their potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acidogenic potential of "sugar-free" cough drops. Mayo, JA., Ritchie, JR.[2021]

A study involving 100 children with sore throats found that testing throat swabs for leukocyte esterase (LE) is as effective as the rapid strep test for diagnosing Group A Beta hemolytic streptococci.

The statistical analysis showed a strong correlation between the results of the rapid strep test and the leukocyte esterase test, indicating that LE testing could be a reliable alternative for quick diagnosis of strep throat in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of Leukocyte Esterase Test Versus Rapid Strep Test for Diagnosis of Acute Strep Pharyngitis. Nibhanipudi, KV.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

CandyCollect: at-home saliva sampling for capture of respiratory pathogens. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

At-Home Saliva Sampling in Healthy Adults Using CandyCollect, a Lollipop-Inspired Device. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Detection of Group A Streptococcus in the Saliva of Children Presenting With Pharyngitis Using the cobas Liat PCR System. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

At-home saliva sampling in healthy adults using CandyCollect, a lollipop-inspired device. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Equal performance of self-collected and health care worker-collected pharyngeal swabs for group a streptococcus testing by PCR. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of Licorice Lollipops in Reducing Dental Caries in a Paediatric Population: A Systematic Review. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Can a licorice lollipop decrease cariogenic bacteria in nursing home residents? [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Antibacterial Efficacy of Emblica Officinalis Lollipop Against Streptococcus Mutans Counts in Institutionalized Visually Impaired Children. [2022]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Acidogenic potential of "sugar-free" cough drops. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Usefulness of Leukocyte Esterase Test Versus Rapid Strep Test for Diagnosis of Acute Strep Pharyngitis. [2020]