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.

• Aquamin (Drug), also known as Nutritional: 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).

Primary outcomes

• Halitosis Associated Life-quality Test (HALT) questionnaire (modified) [90 days (post-intervention)]: 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.

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

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.

• Muhammad N Aslam, Principal investigator, University of Michigan
• Iwonka Eagle, Study director, University of Michigan