Effectiveness of Aquamin® in Mitigating Halitosis

University of Michigan

Status and phase

Enrolling

Phase 2

Conditions

Healthy

Halitosis

Treatments

Drug: Aquamin

Study type

Interventional

Funder types

Other

Identifiers

NCT05058638

HUM00156676 Halitosis substudy

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

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.