Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Rate of ASCA
研究概览
简要总结
This was prospective study randomized in two controlled parallel groups verum versus placebo. The objectives were to assess the influence of antifungal treatment with Fluconazole (FCZ) on the rate of ASCA and endoscopic recurrence at 6 months. The rational was based on our previous research having established i) a link between intestinal inflammation and the opportunistic fungal pathogen C. albicans -a yeast colonizing the human digestive tract- ii) the demonstration that this yeast species could be at the origin of ASCA, a prominent serological marker of CD. It was therefore hypothesized that the FCZ could lower the rate of ASCA and/or reduce the occurrence of recurrences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn disease patients with a small intestine localisation (ileum or ileocecal)
- •Ileal or ileocecal resection in the month before inclusion (resection of all macroscopic lesions). If resection with temporary stoma, the patient may be included at the time of surgery to restore the continuity
- •Patient with low risk of recurrence according to the following criteria:
- •(i) Total length of the resection(s) of the small intestine less than 100 cm (ii) Segmental colectomy leaving in place at least another colonic segment as the rectum
- •Preoperative rate of ASCA> 70 arbitrary units (+/- 10%)
- •Informed consent signed to be involved in the study
排除标准
- •Pregnant women or without adequate contraception
- •Total length of the resection(s) of the small intestine more than 1 meter
- •Subtotal colic resection
- •Preoperative rate of ASCA<63 arbitrary units (+/- 10%)
- •Known hypersensitivity to fluconazole or other azoles
- •Known liver disease or transaminase levels >1.5 the normal rate
- •Patient with renal failure
- •Inability to read and sign the informed consent
研究组 & 干预措施
Placebo
One capsule per day for 6 months
干预措施: Placebo (Other)
Fluconazole
200mg per day for 6 months
干预措施: Fluconazole (Drug)
结局指标
主要结局
Rate of ASCA
时间窗: 6 months
the dosage of ASCA in the serum
次要结局
- Endoscopic recurrence : Rutgeerts Score>1(6 months)
- Appearance or not of a clinical recurrence assessed by Crohn Disease Activity Index (CDAI >=220)(6 months)
- Clinical recurrence : surgery for CD (except for proctological surgery)(6 months)
- Identification of yeast digestive colonization(during 6 months)
- Quantification of yeast digestive colonization(during 6 months)
- Number of patients with adverse events as a measure of safety(during 6 months)