Effectiveness of Aquamin® in Mitigating Halitosis

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.

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.