Aquamin for Bad Breath

Overseen By Muhammad Nadeem Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Calcium, Vitamin D, NSAIDs, others

Disqualifiers: Pregnancy, Gastrointestinal disorders, Kidney disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Aquamin, a natural product from red marine algae, can reduce bad breath when taken for 90 days. Researchers seek to assess whether this supplement makes a noticeable difference for individuals frequently experiencing bad breath. Individuals who have self-reported issues with bad breath and are willing to follow specific study guidelines, such as not brushing their tongue or using mouthwash before visits, might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

If you are taking calcium, Vitamin D, oral steroids, NSAIDs, or antibiotics, you will need to stop them for 30 days before joining the trial.

Is there any evidence suggesting that Aquamin is likely to be safe for humans?

Research has shown that Aquamin, a natural product from red marine algae, is generally safe. Studies found that even at high doses, such as 10 grams per kilogram of body weight, Aquamin did not harm mice. These tests reported no side effects or deaths, indicating that Aquamin is well-tolerated. Overall, the evidence supports Aquamin's safety for humans, with no major safety concerns reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bad breath?

Unlike traditional treatments for bad breath, which often rely on antimicrobial agents or chemical compounds to mask odors, Aquamin offers a unique approach by utilizing a natural mineral complex derived from seaweed. This treatment is exciting because it not only addresses the symptoms of bad breath but also aims to improve oral health by enhancing the mineral balance in the mouth. Researchers are particularly interested in Aquamin's potential to offer a more holistic and sustainable solution, reducing reliance on chemical-based products.

What evidence suggests that Aquamin might be an effective treatment for bad breath?

Research shows that Aquamin®, a mineral supplement from red marine algae, may improve oral health. Studies have found that red marine algae can slow mineral loss from teeth, which is crucial for maintaining their health. It also exhibits strong germ-killing and anti-inflammatory effects. These benefits make it a promising option for managing oral issues, including bad breath. Early evidence suggests that Aquamin® might help reduce bad breath by enhancing overall mouth health. Participants in this trial will receive Aquamin® to evaluate its effectiveness in reducing bad breath. ^{4 6 7 8 9}

Who Is on the Research Team?

James Varani

Principal Investigator

University of Michigan

Muhammad N Aslam

Principal Investigator

University of Michigan

Janet Kinney

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people with self-reported bad breath who are periodontally stable and can consent to study rules. They must not eat, drink, smoke, or use mouthwash an hour before visits and agree not to scrape their tongue during the study. Women must test negative for pregnancy and use birth control.

Inclusion Criteria

I believe I have bad breath.

My gums are healthy and do not have any major issues.

Must be able to give written informed consent

Exclusion Criteria

I have been diagnosed with stomach or intestinal bleeding disorders recently.

I have not taken calcium, vitamin D, steroids, NSAIDs, or antibiotics in the last 30 days.

I have a bleeding disorder or am on blood thinners like Coumadin or heparin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Aquamin® for 90 days to assess its effectiveness in reducing halitosis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aquamin

Trial Overview The trial tests if Aquamin®, a natural multi-mineral supplement from red marine algae, reduces halitosis over 90 days. Participants will take Aquamin® and adhere to specific oral hygiene practices throughout the study.

How Is the Trial Designed?

Group I: Aquamin® Experimental Treatment 1 Intervention

Aquamin is already approved in European Union, United States for the following indications:

Approved in European Union as Aquamin for:

• Digestive health support
• Bone health support

Approved in United States as Aquamin for:

• Dietary supplement for digestive health
• Bone health support

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study analyzing 52 infectious episodes in children, Streptococcus anginosus was most commonly found in genitourinary tract infections, particularly balanoposthitis, which was present in 73% of these cases.

All strains of S. anginosus showed 100% susceptibility to key antibiotics like penicillin and ampicillin, indicating effective treatment options for infections caused by this bacterium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sites of infection associated with Streptococcus anginosus group among children. Furuichi, M., Horikoshi, Y.[2018]

Dental-unit-water-lines (DUWLs) can develop harmful biofilms that contaminate water used in dental treatments, posing infection risks to both patients and dental staff from pathogens like Legionella and Pseudomonas.

Current testing methods for microbial contamination in DUWLs, such as culture on R2A agar plates, are costly and impractical for routine use, highlighting the need for more effective in-office monitoring systems that can reliably ensure compliance with UK guidelines for water safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring dental-unit-water-line output water by current in-office test kits. Lal, S., Singhrao, SK., Bricknell, M., et al.[2021]

A study of water samples from 20 dental offices revealed that only 3.4% of samples met the American Dental Association's standard for water quality, indicating significant microbial contamination in dental unit waterlines.

Out of 59 samples tested, 24% were positive for Pseudomonas species and 30.5% for fungi, highlighting a potential risk for immunocompromised patients due to the presence of opportunistic pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines in Istanbul, Turkey. Göksay, D., Cotuk, A., Zeybek, Z.[2021]

Out of 100 water samples from dental unit waterlines, 37 exceeded the safe limit of 200 colony-forming units (CFU)/mL, indicating significant bacterial contamination that could pose health risks to patients and dental staff.

Pseudomonas aeruginosa was isolated from three dental unit waterlines, but no Legionella or Staphylococcus aureus were found; the study also identified several effective antibiotics, including cefoperazone and ciprofloxacin, against the isolated bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the bacterial load and antibiotic susceptibility of dental units. Güngör, ND., Kadaifçiler, DG., Peker, OÖ.[2022]

In a study of 20 dental offices, 70% of dental unit waterlines were contaminated with high levels of aerobic mesophilic heterotrophic bacteria, which poses a risk to patients and dental staff, especially those with weakened immune systems.

The study found that 90% of dental offices had medium levels of bacterial air contamination, while all offices had low levels of microfungal air contamination, indicating a potential link between water quality and indoor air quality in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines and effect on quality of indoor air. Kadaifciler, DG., Cotuk, A.[2022]

Citations

1. withpower.com withpower.com/trial/phase-3-halitosis-9-2021-a2136

Aquamin for Bad Breath · Info for Participants This trial is testing if Aquamin®, a mineral supplement from red seaweed, can help people with bad breath by improving their mouth health. Show more.

2. ctv.veeva.com ctv.veeva.com/study/effectiveness-of-aquamin-r-in-mitigating-halitosis

Effectiveness of Aquamin® in Mitigating Halitosis The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9963885/

Red Marine Algae Lithothamnion calcareum Supports Dental ... Both experiments showed that LC exhibited equivalent or superior ability to modulate enamel de-remineralization when compared to fluoride solution.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690551/

Mouthwashes: Alternatives and Future Directions - PMC It has shown strong antimicrobial and anti-inflammatory properties, making it a good option for the management of oral disease., Following this, several studies ...

5. mdpi.com mdpi.com/1660-3397/21/2/109/review_report

Red Marine Algae Lithothamnion calcareum Supports ... The present results provide compelling evidence that a multi-mineral natural approach can be beneficial to target the dental hard tissue disorders. LC is not ...

6. aquamin.com aquamin.com/wp-content/uploads/2023/08/4.-Zhang-et-al.-2020.pdf

Evaluation of acute and sub-chronic toxicity of ... Based on these data, the median lethal dose (LD50) of Lithothamnion sp. was > 10 g/kg. BW. 3.2. Sub-chronic toxicity evaluation of Lithothamnion ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7372146/

Evaluation of acute and sub-chronic toxicity ... No adverse effects, and no mortality was observed in mice administered a single dose of 10 g/kg BW of Aquamin F (Lithothamnion sp.). Body weight ...

8. cir-safety.org cir-safety.org/sites/default/files/Red%20Algae.pdf

Safety Assessment of Red Algae-Derived Ingredients as ... Since the review of the Draft Report, the Council has provided considerable additional information regarding the red-algae derived ingredients.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36827150/

Red Marine Algae Lithothamnion calcareum Supports ... The current management of oral conditions such as dental caries and erosion mostly relies on fluoride-based formulations.