Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Aquamin®
干预措施: Aquamin (Drug)
结局指标
主要结局
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
时间窗: 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.
次要结局
未报告次要终点
研究者
Muhammad N Aslam, MD
Associate Research Scientist
University of Michigan