Clinical trial NCT05058638: Effectiveness of Aquamin® in Mitigating Halitosis
Official title: Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Healthy
Halitosis
Keywords: Aquamin®
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
timeFrame: 90 days (post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: James Varani
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Muhammad N Aslam
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Janet Kinney
role: STUDY_DIRECTOR
References: