NCT05058638 Effectiveness of Aquamin® in Mitigating Halitosis
| NCT ID | NCT05058638 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Michigan |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2022-08-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.
Eligibility 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.
Contact & Investigator
Muhammad N Aslam
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05058638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05058638 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05058638 currently recruiting?
Yes, NCT05058638 is actively recruiting participants. Contact the research team at mnaslam@umich.edu for enrollment information.
Where is the NCT05058638 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05058638 clinical trial?
NCT05058638 is sponsored by University of Michigan. The principal investigator is Muhammad N Aslam at University of Michigan. The trial plans to enroll 25 participants.