CelAgace™ OraRinse for Oral Thrush
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of CelAgace™ OraRinse, a solution combining silver citrate complex and acemannan, for treating oral thrush (a yeast infection causing mouth sores). It targets individuals with mouth sores from radiation, chemotherapy, or weakened immune systems that have led to thrush. Those with mild to moderate mouth sores and thrush from these conditions may find this trial suitable. All participants will receive the study treatment to evaluate its effectiveness. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antifungal medication in the last 30 days.
Is there any evidence suggesting that CelAgace™ OraRinse Solution is likely to be safe for humans?
Research shows that the silver citrate complex in CelAgace™ OraRinse works well against yeast in lab tests, suggesting it might be safe for people. Researchers are also studying acemannan to determine its safety and effectiveness for treating oral thrush.
As this is an early-phase trial, the focus remains on testing the treatment's safety and identifying any side effects in people. Early trials typically aim to ensure a treatment's safety and detect any potential side effects, which will be closely monitored if they occur.
While researchers continue to collect safety data, the main goal of this trial is to ensure CelAgace™ OraRinse is safe for use in treating oral thrush.12345Why do researchers think this study treatment might be promising?
Unlike standard treatments for oral thrush, which typically involve antifungal medications like nystatin or fluconazole, CelAgace™ OraRinse is unique because it combines silver citrate complex and acemannan. Silver citrate acts as an antimicrobial agent, while acemannan, derived from aloe vera, has anti-inflammatory and immune-boosting properties. This dual-action approach not only targets the fungal infection but also supports healing and reduces inflammation. Researchers are excited about CelAgace™ OraRinse because it offers a promising alternative by potentially providing faster relief and enhancing oral health beyond just treating the infection.
What evidence suggests that CelAgace™ OraRinse might be an effective treatment for oral thrush?
Research has shown that CelAgace™ OraRinse, a combination of silver citrate and acemannan, may help treat oral thrush, a common yeast infection in the mouth. Silver citrate can kill or inhibit the growth of germs like yeast. Acemannan, derived from aloe vera, is believed to support the immune system and aid healing. Although limited data exists on CelAgace™ OraRinse's effectiveness in people, these ingredients have proven effective in early studies. The treatment aims to reduce yeast levels and promote healing in the mouth.14678
Who Is on the Research Team?
Jacqueline M. Plemons, DDS, MS
Principal Investigator
Texas A&M University College of Dentistry
Are You a Good Fit for This Trial?
This trial is for adults with mild to moderate oral thrush due to immunocompromise or treatments like chemotherapy. It's not for pregnant/breastfeeding individuals, those who can't use an oral rinse, have a history of oral cancer, used antifungals recently, are allergic to Aloe Vera/Silver, wear removable dental appliances, or have severe mouth sores.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants will swish and spit the product 4 times daily for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CelAgace™ OraRinse Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
CelaCare Technologies, Inc.
Lead Sponsor
Texas A&M University
Collaborator