NL-OMON51473招募中2 期
The chemopreventive effect of Lithium on adenoma development in patients with familial adenomatous polyposis (FAP); a pilot study - Lithium in FAP
Amsterdam UMC0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Male or female between the age of 18 and 35 years;
- •- Confirmed APC germline mutation;
- •- Positive family history of a classical FAP phenotype (>100 colorectal
- •- Intact colon, with a minimum of 50 polyps;
- •- Participant is willing and able to give informed consent for participation
排除标准
- •- Participation in any other clinical intervention study; observational trials
- •- Lithium use prior to participation of the study;
- •- Pregnancy, breast-feeding or no use of anticonception;
- •- No normal intestinal mucosa left for normal tissue biopsy;
- •- Indication for colectomy within 2 years;
- •- Known renal impairment, defined as GFR < 60 ml/min;
- •- Known severe cardiac disorder;
- •- Known severe brain injury;
- •- Hypothyroidism;
- •- Hyponatremia, defined as Na < 130mmol/L;
- •- Positive family history of Brugada syndrome
- •- Co-medication known for interacting with Lithium (as defined in the protocol).
- •- Regular NSAID use (defined as more than twice a week for 4 consecutive weeks)
- •within 3 months prior to baseline;
- •- Use of immunosuppressive or anti-inflammatory drugs within 3 months prior to
- •- Use of any other FAP directed drug therapy within 3 months prior to baseline
- •(use of any alternative supplements e.g. turmeric or fish-oil must be noted in
- •questionnaire).
研究者
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