Aquamin® for reducing bad breath in adults
Official title: Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
Run by University of Michigan · NCT05058638 · Data updated 2026-11-12
This study tests whether Aquamin®, a multi-mineral product from red marine algae, can reduce halitosis after 90 days in adults who report bad breath.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | August 15, 2022 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT05058638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with stable oral health who self-report halitosis and are willing to follow pre-visit instructions and birth control requirements.
✕Probably not a fit
Individuals with active gastrointestinal disease, pregnancy, or other exclusion criteria may not experience any halitosis improvement from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 interventional sub-study evaluating Aquamin® as an add-on approach for halitosis. Participants will follow specific pre-visit precautions and have stable oral health with self-reported halitosis. The study is a sub-study of an ongoing trial in ulcerative colitis and its remission, though this halitosis study itself focuses on breath impact. Enrollment is limited to adults at the University of Michigan with a commitment to informed consent and adherence to study procedures. FDA did not require an Investigational New Drug application for this product in this context.
Why it matters
Potential benefit: If successful, participants may experience a reduction in the severity or frequency of halitosis after 90 days of Aquamin® use.
How similar studies have gone: Previous similar approaches with mineral-based strategies have shown variable results; this sub-study explores a focused breath outcome in halitosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be able to give written informed consent * Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visits * Have stable oral health * Self-reported halitosis * A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and the subject must agree to use appropriate birth control over the study period. Exclusion Criteria: * Pregnant or lactating women * Participating in any other interventional trials using an investigational drug * Diagnosed with any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors) or active gastric/duodenal ulcers - peptic ulcer disease (in last 3 months) or with severe symptoms of ulcerative colitis or Crohn's disease * Any gastrointestinal or colonic malignancy; kidney disease, including kidney "stones" or hypercalcemia * Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin * Have any severe oral condition that, in the opinion of the oral healthcare provide might impact the results of the study if the condition is treated * Have been treated for oral cancer within the past year * Taking any of the following within 30 days (will be eligible after completing 30 days of washout period): Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.
Where it's running
-
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Muhammad N Aslam — University of Michigan
- Study coordinator: Muhammad N Aslam
- Email: mnaslam@umich.edu
- Phone: 734-936-1897
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.