DRKS00000234已完成2 期
Mutaflor Enemas in the Treatment of Idiopathic Proctitis / Proctosigmoiditis - MU 9912
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Acute idiopathic proctitis/proctosigmoiditis with light to moderate disease activity.
- •Definition of active disease:
- •- Disease Activity Index (DAI) according to Sutherland: 4 - 9.
- •- Definition of proctitis: Inflammation beginning at the anus up to <=15 cm.
- •- Definition of proctosigmoiditis: Inflammation beginning at the anus to end of colon sigmoideum (about 25 - 30 cm from anus). No endoscopic or histological signs of inflammation beyond that point.
- •- Age 18 - 70 years.
- •- At least two manifestations of the disease (confirmed diagnosis).
- •- Written volunteer informed consent form.
排除标准
- •- Other causes of acute proctitis/proctosigmoiditis:
- •infection, medical drugs, radiation, ischaemia of affect
- •intestinal segment,
- •- Crohn's disease.
- •- History of stool incontinence.
- •- Perianal fistulae.
- •- Major colon surgery (colectomy, partial or total).
- •- Colorectal carcinoma.
- •- Colon stenoses.
- •- Intake of Mutaflor capsules or suspension less than 4 weeks
- •before start of the study or during the study.
- •- Rectal treatment with steroids (absorbable or non-absorbable)
- •or aminosalicylates within 2 weeks prior to inclusion in the
- •- Intake of immunosuppressants less than 90 days before
- •inclusion in study.
- •- Severe accompanying diseases:
- •- Cardiac diseases (coronary heart disease, cardiac
- •infarction, angina pectoris, cardiac insufficiency,
- •NYHA III - IV).
- •- Liver diseases (cirrhosis, acute or soon after hepatitis,
- •proliferative chronic liver disease).
- •- Renal diseases (creatinine value outside reference
- •- Other severe chronic or terminal diseases (e.g. cancer,
- •tuberculosis)
研究者
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