Effectiveness of Aquamin® in Mitigating Halitosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)

Conditions
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Healthy, Halitosis

Intervention / Treatment
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* Drug: Aquamin


Participation Criteria
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Eligibility Criteria
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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 Willing to not scrape their tongue with a toothbrush, oral hygiene aid, or other utensil during the study participation Periodontally stable Self-reported halitosis A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and 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 Presence of one or more cavitated carious lesions, untreated dental abscesses (endodontic or periodontal), untreated periodontitis (gum disease), or oral pathologies that may contribute to oral malodor (e.g., candidiasis, erosive gingival conditions) Taking any of the following within 30 days (will be eligible after completing 30 days of wash out period): Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aquamin®<br> | Drug: Aquamin<br>* Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).<br>* Other names: Nutritional;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Halitosis Associated Life-quality Test (HALT) questionnaire (modified) | Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question. | 90 days (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aquamin®