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

Overseen By Man Hung (Primary Investigator), PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: USANA Health Sciences

Must not be taking: Probiotics, Antibiotics, Antifungals, Antiseptics

Disqualifiers: Pregnancy, Alcohol, Marijuana, Tobacco, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

105 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{4 11 12 13 14}

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

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

Group I: : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1) Experimental Treatment 2 Interventions

1 active oral probiotic with placebo toothpaste

Group II: Oral probiotic lozenges + toothpaste with ADP-1 Active Control 1 Intervention

Oral probiotic and ADP1 toothpaste

Group III: Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1) Placebo Group 1 Intervention

Placebo without oral probiotics or ADP1 toothpaste

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

Probiotics are widely used, with over 20 billion doses taken annually, and are generally considered safe with very few serious side effects reported.

There is a need for standardized criteria to define what qualifies as a 'probiotic' to ensure products meet safety and efficacy standards, especially as new products enter the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? Reid, G.[2007]

References

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

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Probiotics and prebiotics in clinical tests: an update. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Indications for the use of probiotics in gastrointestinal diseases. [2022]

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

Responders and non-responders to probiotic interventions: how can we improve the odds? [2022]

5. England pubmed.ncbi.nlm.nih.gov

Probiotics in the intensive care unit: why controversies and confusion abound. [2021]

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

Risk and safety of probiotics. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? [2014]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Probiotic and synbiotic safety in infants under two years of age. [2014]

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

Clinical research on probiotics: the interface between science and regulation. [2008]

10. England pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? [2007]

11. Denmark pubmed.ncbi.nlm.nih.gov

The longitudinal impact of probiotic and peanut oral immunotherapy on health-related quality of life. [2022]

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

Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled trial of Lactobacillus helveticus and Bifidobacterium longum for the symptoms of depression. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. [2017]