ACTRN12612000804886已完成2 期
A double blind, placebo controlled, randomised cross over trial to evaluate a novel and cost effective food supplement, butyrylated starch, on polyposis in familial adenomatous polyposis (FAP) patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Medically diagnosed FAP with either an intact colon, or after colectomy with a residual ileorectal anastomosis (IRA) or ileal pouch
- •2. History of polyp detection at surveillance sigmoidoscopies or colonoscopies
- •3. Generally in good health
- •4. Available for the duration of the study
排除标准
- •1.Intolerant to high fibre products
- •2.Reported lactating, pregnant or wish to become pregnant during the study. If a participant becomes pregnant during the trial they will be withdrawn
- •3.Reported use of nonsteroidal anti-inflammatory drugs, aspirin or probiotics
- •4.Use of other medication or supplement that in the opinion of the gastroenterologist may interfere with polyp development or bowel or microbiota function for 2 months prior to and during the clinical intervention. Use of anti-diarrhoeal medication(s) is allowed as required
- •5.Use of antibiotics for 2 months prior to the commencement of the trial
- •6.Use of other experimental chemopreventative agents, including EPA, tumeric and curcumin for 6 months prior to and during the trial
- •7.Colonic or rectal surgery likely within 18 months.
研究者
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