Distribution of FMT After Delivery by · Lower GI Endoscopy vs· Enema With and Without Positioning of the Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Proportion of cecum projection after CF delivery by lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.
研究概览
简要总结
While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is uncertain whether delivery by enema distributes the FMT to the proximal segments of the colon. Positioning of the patient during the enema procedure may improve distribution to the proximal colon. Differences in distribution may explain the wide effect range and inferiority when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare the distribution of FMT from delivery by lower GI endoscopy versus enema with and without positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to project the distribution on colon X-ray pictures. To our knowledge this is not done in any previous study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for colonoscopy at the medical department at UNN Harstad
- •Able to complete the positioning procedure during the enema
排除标准
- •Confirmed malignancy
- •Inflammatory bowel disease
- •Referral highly suspicious of cancer, inflammatory bowel disease or obstructive GI disease
- •Contraindications for rectal catheter insertion (including known damage to pelvic floor, sphincter or the pudendal nerve)
- •Use of anticoagulants. Use of acetylsalicylic acid is allowed
- •Symptomatic cardiovascular or lung disease
- •Kidney failure
- •Known allergic reaction to any component in Liquid Polibar Plus
- •Pregnant, lactating or planning pregnancy
研究组 & 干预措施
Contrast fluid by lower GI endoscopy and enema with and without positioning
There is a washout period of at least four weeks between the two interventions (delivery by lower GI endoscopy and enema)
干预措施: Delivery of contrast fluid by lower GI endoscopy (Other)
Contrast fluid by lower GI endoscopy and enema with and without positioning
There is a washout period of at least four weeks between the two interventions (delivery by lower GI endoscopy and enema)
干预措施: Delivery of contrast fluid by enema with and without positioning (Other)
结局指标
主要结局
Proportion of cecum projection after CF delivery by lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.
时间窗: 10 minutes after contrast fluid delivery
Two radiologist determine the projection each colon X-ray picture by identifying segments where the gut mucosa is coated with contrast fluid and/or segments with contrast fluid in the lumen. The radiologist is blinded to which delivery method is used.
次要结局
- Proportion of transverse colon projection after CF delivery by the lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.(10-20 minutes after contrast fluid delivery)