Effectiveness of Aquamin® in Mitigating Halitosis

University of Michigan

Status and phase

Active, not recruiting

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

15 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
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.