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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquamin® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad N Aslam | University of Michigan | Principal Investigator |
| Janet Kinney | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C572820 | Aquamin |
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