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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

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Conditions

HealthyHalitosis

Locations

University of Michigan School of Dentistry

Ann Arbor, Michigan 48109

United States