A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events of Hydroxocobalamin Drug
研究概览
简要总结
We are planning a series of studies in individuals with ulcerative colitis, primary sclerosing cholangitis and pouchitis to determine if hydroxocobalamin is an effective therapy to treat these conditions. For these indications we are submitting INDs to the FDA as well as protocols to the IRB. Hydroxocobalamin, referred to as vitamin B12a has been approved by the FDA for treatment of cyanide toxicity in up to 5 grams intravenously over 15 minutes twice in a brief period. This has been tested and used in intravenous doses as high as 15 grams in a day. We will be utilizing its pharmacokinetic and safety profile to treat several subsets of patients. We are testing this initially in a healthy population to assess tolerability.
详细描述
Patients will be recruited at Brigham and Women's Hospital (BWH), at both the main campus and 850 Boylston Street locations. Healthy subjects may be identified as family members of patients who are picking them up from colonoscopy procedures or through the Mass General Brigham Rally system. Flyers and emails will inform interested subjects of the trial and will assist with recruitment.
Patients may be identified by their physician or by a research coordinator with physician permission. Patients identified by their healthcare providers who may meet entry criteria would be approached by a study team member to explain about the trial in more detail and to offer participation. In collaboration with their physician, the patient will decide whether to consent and participate.
We aim to enroll up to 10 individuals for the study. Individuals will be requested to maintain their diets in their usual intake and avoid those foods which they are aware that may induce diarrhea or looser stools for them.
Patients will be given different oral doses of hydroxocobalamin to assess tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-70
- •Ability to give consent
排除标准
- •Patients who are pregnant or breastfeeding
- •Use of chronic medications
- •History of hypersensitivity to hydroxocobalamin
- •History of chronic constipation or diarrhea
- •History of IBS or other GI illness which causes symptoms of diarrhea or constipation
研究组 & 干预措施
Hydroxocobalamin
干预措施: Hydroxocobalamin (Drug)
结局指标
主要结局
Adverse Events of Hydroxocobalamin Drug
时间窗: 2 weeks
Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms
次要结局
未报告次要终点
研究者
Joshua Korzenik
Director of Crohn's and Colitis Center
Brigham and Women's Hospital