Halitosis, Healthy
Conditions
Keywords
Aquamin®
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.
Interventions
DRUGAquamin
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).
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTMuhammad N Aslam
PRINCIPAL_INVESTIGATORMuhammad N Aslam
University of Michigan
STUDY_DIRECTORIwonka Eagle
University of Michigan
Outcome results
None listed