Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score
研究概览
简要总结
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
- •A negative pregnancy test
排除标准
- •No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
- •Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.
研究组 & 干预措施
Aquamin®
To be taken for 180 days
干预措施: Aquamin® (Drug)
Placebo first then Aquamin®
Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
干预措施: Aquamin® (Drug)
Placebo first then Aquamin®
Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
干预措施: Placebo first then Aquamin® (Drug)
结局指标
主要结局
Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score
时间窗: Up to day 180
This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life.
Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring
时间窗: Up to day 180
UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)
时间窗: Up to day 180
Interleukin 8 levels are measured in picograms per milliliter (pg/mL)
Change in serum C-reactive protein (CRP) levels as measured in a blood sample.
时间窗: Up to day 180
Serum C-reactive protein (\[CRP levels)\] will be reported in milligram per deciliter (mg/dL)
Change in fecal calprotectin levels measured in a stool sample
时间窗: Up to day 180
Fecal calprotectin will be reported in microgram per gram (µg/g)
次要结局
- Changes in serum liver function tests(Up to day 180)
研究者
Muhammad N Aslam, MD
Associate Research Scientist
University of Michigan