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临床试验/NCT00856648
NCT00856648已完成不适用

SmartPill Monitoring for Assessment of GI Function in SCI

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Colonic transit time (CTT)

研究概览

简要总结

The present study aims to evaluate the relationship between the level of SCI and the impairment of Colonic transit time (CTT) and Total transit time (TTT) by using the SmartPill device. The SmartPill, an FDA approved device, is a wireless capsule that is ingested and transmits values for GI pH, temperature, and pressure as it travels throughout the digestive system. The SmartPill can also be used to assess CTT and TTT. In comparing values for CTT, TTT, pH, temperature, and pressure in SCI patients to healthy, able-bodied controls, the SmartPill device may provide valuable insight into the pathophysiological implications of SCI on GI function. This information may allow medical professionals to provide more effective plans of care for this population, subsequentially enhancing quality and quantity of life. The SmartPill device may also provide a less invasive alternative to assessing these variables, compared to traditional modalities.

详细描述

Total Transit Time Total transit time (TTT) is simply the amount of time (hours) it takes for a meal to travel from the mouth, through the digestive tract and for its waste by-products to be eliminated through a bowel movement. Inter-individual TTT can vary greatly due to dietary habits, age, climate, exercise habits, immobility, medications and other lifestyle variables. Due to these multiple variables, a general TTT for the public cannot be determined. It is clear however, that a healthy person should have a total transit time ranging from 8 to 14 hours, resulting in one to three loose bowel movements every 24 hours. People who are in good physical condition, consume fiber-rich diets, and take no constipating medications are most likely to have a normal TTT. Colonic transit time (CTT) is the amount of time it takes for a partially digested meal to travel from the terminal ileum, through the large bowel and for its waste by-products to be eliminated through a bowel movement.

There are several ways to measure TTT. Each requires ingesting a tracking device or a tracer that can be monitored as it moves throughout the digestive system.

Total transit time has been traditionally measured using radiopaque markers1. This technique is simple and inexpensive and can be performed in any radiology department. Several other methods have been suggested, including the single-marker bolus technique (ingestion of markers on a specific day followed by several x-rays until all markers are passed) or multiple-marker bolus technique (ingestion of markers each day for several days followed by single or multiple abdominal x-rays). Radiopaque markers have been widely used to measure total transit. This technique provides valuable clinical information and has been proven to be reliable and reproducible.

Scintigraphy can be used as an alternative to the radiopaque marker technique for measuring TTT. The tagged material is surrounded by a substance that dissolves once it arrives at the colon. Another technique widely used in the past is the Hydrogen Breath Test which measures the transit time of the meal from the mouth to the cecum. The meal reaching the colon is indicated by a rise in the relative hydrogen content in exhaled air2,3. While many valid GI assessment techniques exist, many are invasive and impose many inconveniences for patients.

A relatively new device, the SmartPill, offers the ability to assess many GI variables including temperature, pressure, pH, and transit time while minimizing the invasive nature of investigation. The SmartPill is a small wireless capsule that is ingested by the patient. Values for pressure, temperature, and pH are transmitted continuously from the capsule to a receiver carried by the patient until the capsule is excreted during normal evacuation. This information is then downloaded onto a master computer and expressed graphically for comparative purposes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 to 75
  • Spinal cord lesion at any level at least 6 months from injury
  • The patient is able to understand the treatment and is willing to comply with the prescribed regimen
  • At least one or more of the following symptoms:
  • Bowel program >30 minutes
  • Episodes of fecal incontinence once or more per month

排除标准

  • Inadequately managed complications related to SCI
  • Evidence of bowel obstruction
  • Evidence of inflammatory bowel disease
  • History of cerebral palsy or cerebral apoplexy
  • Multiple sclerosis
  • Diabetic polyneuropathy
  • Previous abdominal or perianal surgery including Hernia repair , total polyp removal (not including minor surgery as appendectomy or haemorrhoidectomy)
  • Pregnant or lactating
  • Evidence of spinal shock
  • Mentally unstable
  • Treatment with more than 5 mg prednisolon per day.
  • PNS implant (sacral nerve stimulation)
  • History of gastric ulcers
  • Disorders of swallowing
  • Suspected strictures, fistulas or physiological GI obstruction.
  • GI surgery within past three months
  • Severe dysphagia to food or pills
  • Crohns disease or diverticulitis
  • Use of implanted or portable electro-mechanical medical devices such as cardiac pacemakers or infusion pumps.
  • Known intolerance to the SmartPill device
  • Known food allergies to any component of the standard meal

结局指标

主要结局

Colonic transit time (CTT)

时间窗: 1-4 days

次要结局

  • Total transit time (TTT)(1-4 days)
  • Gastric emptying time (GET)(1-10 hours)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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