Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Sperm motility
研究概览
简要总结
The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with crohn's disease.
详细描述
The highest age- and sex-adjusted incidence rates for Crohn's Disease (CD) occur during the peak reproductive years. In addition, gastroenterologists frequently advise and manage patients with CD who desire to conceive. Enteral nutrition therapy is effective for induction and maintenance of remission in reproductive age men with CD. However, there is no available data on the effects of enteral nutrition therapy on semen quality. The purpose of this study is to investigate the impact of enteral nutrition therapy on sperm quality of patients with CD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Crohn' Disease
- •Male patients
- •Age: 18-40 years old
- •Receive 3-months exclusive enteral nutrition therapy
排除标准
- •Used any experimental therapy in the 8 weeks before study entry date
- •Had previously documented problems with male reproductive health, such as low sperm count, impotence, or malignancy
- •The use of concomitant medication including sulphasalazine, 5-aminosalicylic acid or other immune-suppressives.
- •Unable to complete the 3-months exclusive enteral nutrition therapy.
研究组 & 干预措施
Semen quality
干预措施: Exclusive Enteral Nutrition Therapy (Dietary Supplement)
结局指标
主要结局
Sperm motility
时间窗: Up to 3 months
Sperm motility is a useful marker of sperm quality. The normal level of sperm motility (World Health Organization criteria) should be higher than 50%.
次要结局
- Crohn's Disease Activity Index(Up to 3 months)
研究者
Jianan Ren
Vice president
Jinling Hospital, China