NCT05058638PHASE2RecruitingAccepts Healthy Volunteers
Effectiveness of Aquamin® in Mitigating Halitosis
University of Michigan
Start Date
8/15/2022
Completion Date
12/1/2027
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.
Detailed Description
This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905. However, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.
Eligibility Criteria
Age Range: 18 years to 99 years
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.
Interventions
DRUG
Aquamin
Conditions
HealthyHalitosis
Locations
University of Michigan School of Dentistry
Ann Arbor, Michigan 48109
United States