Background: 

There is an emerging role of fungal dysbiosis in the pathogenesis of inflammatory bowel disease. Prevalence of Candida in patients with active ulcerative colitis (UC) and the effect of fluconazole therapy in reducing disease activity of UC are not known.

Patients and Methods: 

All consecutive consenting patients with active UC defined as Mayo score ≥3 were evaluated for presence of Candida by stool culture and predictors for presence of Candida were identified. Those who had evidence of Candida in the stool were randomized to receive oral fluconazole 200 mg daily or placebo for 3 weeks along with standard medical therapy. Patients were assessed by clinical, sigmoidoscopy, and laboratory parameters at baseline and at 4 weeks. The primary outcome was clinical and endoscopic response at 4 weeks defined by a 3-point reduction in Mayo score. Secondary outcomes were reduction in fecal calprotectin, histologic response, and adverse events.

Results: 

Of the 242 patients with active UC, 68 (28%) patients had Candida in stool culture. Independent predictors for presence of Candida in patients with active UC were partial Mayo score of ≥3 and steroid exposure. Among those with Candida on stool culture (n=68), 61 patients fulfilled eligibility criteria and were randomized to receive fluconazole (n=31) or placebo (n=30). Three-point reduction in Mayo score though was numerically higher in the fluconazole group than the placebo group but was not statistically significant [5 (16.1%) vs. 1 (3.33%); P=0.19]. Postintervention median Mayo score was lower in fluconazole than placebo group [4 (3, 5) vs. 5 (4, 6); P=0.034]. Patients in fluconazole group had more often reduction in fecal calprotectin [26 (83.9%) vs. 11 (36.7%); P=0.001] and histologic scores [23 (74.1%) vs. 10 (33.3%); P=0.001] compared with placebo. All patients were compliant and did not report any serious adverse event.

Conclusion: 

Candida colonization is found in 28% of patients with UC. Steroid exposure and active disease were independent predictors for the presence of Candida. There was no statistically significant difference in the number of patients who achieved 3-point reduction in Mayo score between 2 groups. However, clinical, histologic, and calprotectin levels showed significant improvement in fluconazole group.

中文翻译：

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口服氟康唑治疗粪便中可检测到念珠菌的活动性溃疡性结肠炎患者：一项双盲随机安慰剂对照试验

背景： 

真菌失调在炎症性肠病的发病机制中发挥着新的作用。活动性溃疡性结肠炎 (UC) 患者中念珠菌的患病率以及氟康唑治疗降低 UC疾病活动度的效果尚不清楚。

患者和方法： 

通过粪便培养评估所有连续同意的活动性 UC 患者（定义为 Mayo 评分≥3）是否存在念珠菌，并确定念珠菌存在的预测因子。那些粪便中有念珠菌证据的患者被随机接受每日口服氟康唑 200 毫克或安慰剂，持续 3 周，同时接受标准药物治疗。在基线和 4 周时通过临床、乙状结肠镜检查和实验室参数对患者进行评估。主要结局是 4 周时的临床和内镜反应，定义为 Mayo 评分降低 3 分。次要结局是粪便钙卫蛋白的减少、组织学反应和不良事件。

结果： 

在 242 名活动性 UC 患者中，68 名 (28%) 患者的粪便培养中有念珠菌。活动性 UC 患者存在念珠菌的独立预测因素是部分 Mayo 评分≥3 和类固醇暴露。在粪便培养中有念珠菌的患者(n=68) 中，61 名患者符合资格标准，并随机接受氟康唑 (n=31) 或安慰剂 (n=30) 治疗。虽然氟康唑组 Mayo 评分减少 3 分的数值高于安慰剂组，但没有统计学意义 [5 例 (16.1%) 比 1 例 (3.33%)；P =0.19]。氟康唑组干预后 Mayo 评分中位数低于安慰剂组 [4 (3, 5) vs. 5 (4, 6)；P =0.034]。氟康唑组患者粪便钙卫蛋白减少的情况更为常见[26 例 (83.9%) vs. 11 例 (36.7%)；P = 0.001] 和组织学评分 [23 (74.1%) vs. 10 (33.3%)；P = 0.001]与安慰剂相比。所有患者均依从治疗，未报告任何严重不良事件。

结论： 

28% 的 UC 患者中发现念珠​​菌定植。类固醇暴露和活动性疾病是念珠菌存在的独立预测因子。两组间 Mayo 评分降低 3 分的患者数量无统计学差异。然而，氟康唑组的临床、组织学和钙卫蛋白水平显示出显着改善。