Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes in fecal calprotectin levels
研究概览
简要总结
The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged between18 and 80 years.
- •Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
- •Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI < 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
- •Fecal calprotectin at baseline > 150 μg/g.
排除标准
- •Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI ≥ 1 and a CDAI ≥
- •Patients on steroid therapy.
- •Patients in therapy wih warfarin or other anticoagulants.
- •Known or supposed ipersensitivity to eicosapentaenoic acid/omega
- •Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
- •Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
- •Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
- •Patients unable to follow protocol procedures and to sign the informate consent.
研究组 & 干预措施
Medium chain fatty acid (placebo)
Subjects with Crohn's Disease and/or Ulcerative colitis will be receive 2 g/day of medium chain fatty acid for 6 months
干预措施: Medium chain fatty acid (placebo) (Dietary Supplement)
Eicosapentaenoic acid
Subject with Cronn's Disease and/or Ulcerative colitis in clinical remission will receive 2 g/day of eicosapentaenoic acid for 6 months
干预措施: Eicosapentaenoic acid (Dietary Supplement)
结局指标
主要结局
changes in fecal calprotectin levels
时间窗: baseline, 3 months and at 6 months
次要结局
- number of clinical flares of diseases(at 6 months)
研究者
andrea belluzzi, MD phD
Consultant in Gastroenterology
IRCCS Azienda Ospedaliero-Universitaria di Bologna