Effectiveness of Aquamin® in Mitigating Halitosis

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058638
• Other study ID #: HUM00156676 Halitosis substudy
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2022
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Muhammad Nadeem Aslam
• Phone: 734-936-1897
• Email: mnaslam[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Halitosis
• Healthy

Intervention

Drug:
• Aquamin
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).

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)