105 Participants Needed

The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

RM
MH
Overseen ByMan Hung (Primary Investigator), PhD

Trial Summary

Will I have to stop taking my current medications?

Yes, if you are currently taking oral probiotics, antibiotics, antifungal medications, antiseptic medications, immunosuppressants, chemotherapeutic medications, or certain medications that affect gum response, you will need to stop taking them at least 30 days before joining the trial.

What data supports the effectiveness of the treatment Oral probiotic?

Probiotics have shown some effectiveness in treating gastrointestinal issues like diarrhea and inflammatory bowel diseases by improving gut health and immune function. However, results can vary widely depending on the specific probiotic strain and condition being treated, and not all studies show consistent benefits.12345

Is the treatment generally safe for humans?

Probiotics, including those used as oral treatments, are generally considered safe for most people, with a long history of use and no major safety concerns reported in clinical trials. However, there are some theoretical risks, and more research is needed to fully understand the safety profile, especially in specific populations.678910

How does the oral probiotic treatment differ from other treatments for this condition?

The oral probiotic treatment is unique because it uses beneficial bacteria to potentially improve health outcomes, unlike traditional treatments that may rely on pharmaceuticals. Probiotics can help balance gut bacteria, which might improve symptoms related to stress, mood, and gastrointestinal issues, offering a natural alternative to conventional therapies.411121314

What is the purpose of this trial?

This trial tests if taking beneficial bacteria by mouth and using a new type of toothpaste can improve oral health better than regular toothpaste.

Eligibility Criteria

Inclusion Criteria

Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)
Able to perform oral hygiene adequately after formal instructions
Able to understand and comply with study procedure
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral probiotic intervention with or without a novel ADP-1 toothpaste

8 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Oral probiotic
  • Placebo
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1)Experimental Treatment2 Interventions
1 active oral probiotic with placebo toothpaste
Group II: Oral probiotic lozenges + toothpaste with ADP-1Active Control1 Intervention
Oral probiotic and ADP1 toothpaste
Group III: Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1)Placebo Group1 Intervention
Placebo without oral probiotics or ADP1 toothpaste

Find a Clinic Near You

Who Is Running the Clinical Trial?

USANA Health Sciences

Lead Sponsor

Trials
12
Recruited
760+

Roseman University of Health Sciences

Collaborator

Trials
5
Recruited
600+

Findings from Research

In a study involving 77 patients with chronic inflammatory rhinosinusitis, the probiotic Lactobacillus rhamnosus R0011 showed a significant improvement in quality of life at 4 weeks, but this effect did not persist at 8 weeks.
Overall, there were no significant differences in quality of life improvements or symptom frequency between the probiotic and placebo groups, indicating that the probiotic did not provide a meaningful benefit over placebo in this patient population.
Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial.Mukerji, SS., Pynnonen, MA., Kim, HM., et al.[2022]
Probiotics have a long history of safe use, and while clinical trials generally show no increased risk, the current literature lacks comprehensive safety reporting, making it difficult to draw definitive conclusions about their safety in intervention studies.
Theoretical risks associated with probiotics include systemic infections and gastrointestinal side effects, highlighting the need for further research to accurately assess the incidence and severity of any adverse events related to their use.
Risk and safety of probiotics.Doron, S., Snydman, DR.[2022]
A systematic review of 57 clinical studies found that probiotics and synbiotics are safe for immune-compromised adults, with no serious adverse events linked to these products, indicating they are well tolerated.
Probiotics and synbiotics resulted in fewer adverse events compared to control groups, but the study highlighted issues with inconsistent reporting of adverse events, suggesting a need for standardized reporting to enhance data reliability.
The administration of probiotics and synbiotics in immune compromised adults: is it safe?Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

References

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. [2022]
Probiotics and prebiotics in clinical tests: an update. [2020]
Indications for the use of probiotics in gastrointestinal diseases. [2022]
Responders and non-responders to probiotic interventions: how can we improve the odds? [2022]
Probiotics in the intensive care unit: why controversies and confusion abound. [2021]
Risk and safety of probiotics. [2022]
The administration of probiotics and synbiotics in immune compromised adults: is it safe? [2014]
Probiotic and synbiotic safety in infants under two years of age. [2014]
Clinical research on probiotics: the interface between science and regulation. [2008]
Safe and efficacious probiotics: what are they? [2007]
The longitudinal impact of probiotic and peanut oral immunotherapy on health-related quality of life. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial. [2023]
A double-blind, randomized, placebo-controlled trial of Lactobacillus helveticus and Bifidobacterium longum for the symptoms of depression. [2023]
Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. [2017]
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