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SmartPill Monitoring for Assessment of GI Function in SCI

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ClinicalTrials.gov Identifier: NCT00856648
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date March 4, 2009
First Posted Date March 6, 2009
Last Update Posted Date May 23, 2012
Study Start Date April 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2009)
Colonic transit time (CTT) [ Time Frame: 1-4 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2010)
  • Total transit time (TTT) [ Time Frame: 1-4 days ]
  • Gastric emptying time (GET) [ Time Frame: 1-10 hours ]
Original Secondary Outcome Measures
 (submitted: March 5, 2009)
Total transit time (TTT) [ Time Frame: 1-4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SmartPill Monitoring for Assessment of GI Function in SCI
Official Title SmartPill Monitoring for Assessment of GI Function in SCI
Brief Summary 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.
Detailed Description

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.

Purpose of measuring TTT Measuring TTT is useful in evaluating patients with constipation, abdominal bloating, and refractory irritable bowel syndrome. It provides quantitative information about total transit, enables the identification and characterization of transit abnormalities, and allows assessment of the severity of the problem as well as the response to therapy.

Disorders Affecting TTT Intestinal Motility Disorder (IMD) may be due to primary or secondary causes depending on endogenous or exogenous etiologies. This would include several asymptomatic conditions, such as maldigestion, achalasia, or alkaline bile reflux from the duodenum to the stomach. Intestinal pseudo-obstruction (Ogilvie syndrome), irritable bowel syndrome (IBS), fecal incontinence, and constipation are all conditions related to disordered intestinal motility. Many common drugs (tricyclic antidepressants, diuretics, laxatives, lithium salts, vinca alkaloids, chemotherapy agents, etc.) may interfere with intestinal motility on the receptor level or by interfering with the parasympathetic nervous system, which largely controls GI motility. Drugs such as benzodiazepines, lithium salts, laxatives, and codeine cause secondary stasis4. The latter can produce narcotic bowel syndrome, which is usually observed in patients who abuse opiates for chronic pain. Endocrine disorders, such as myxedema, can also cause gastrointestinal obstruction due to the decrease in the thyroid hormone level as well as an imbalance in sodium and potassium metabolism.

CTT in SCI patients The magnitude of bowel dysfunction in spinal cord injury patients has been documented in several studies. Spinal cord injury affects colorectal motility, transit times, and bowel emptying, often leading to constipation, fecal incontinence or a combination of the two. Although these symptoms are not life-threatening, they may negatively impact quality of life as well as increase levels of anxiety and depression5.

Abnormal bowel function is one of the most bothersome problems in patients with SCI. While it is known how bowel dysfunction affects quality of life, research examining the pathophysiological causes of bowel dysfunction are limited. Moreover, most studies have provided only partial information on bowel dysmotility, focusing on only CTT or anal dysfunction, rather than identifying a comprehensive neurogenic bowel pattern according to different neurological abnormalities and clinical manifestations.

Constipation, obstructive defecation, and fecal incontinence are known to be frequent complications in SCI. However, their presence and severity are not homogeneous in all patients and depend on the integration of mechanisms such as abdominal compression, colorectal motor activity, and anal sphincter function as well as digitalization for bowel evacuation. Paralleling these complications, CTT is increased in SCI subjects when compared with the normal populations. Recent clinical studies of individuals with SCI have identified prolonged CTT in 57% of the subjects6. While these studies investigated the correlation between intestinal symptoms and the level of SCI, the relationship between intestinal symptoms and the changes in CTT were not evaluated. While several studies have identified prolonged CTT in SCI patients, other investigations have not produced consistent findings7, 8.

The present study aims to evaluate multiple variables of GI function in both patients with SCI and able-bodied controls using the SmartPill device. In comparing values for TTT, CTT, pH, temperature, and pressure in patients with SCI to healthy, able-bodied controls, the SmartPill device may provide valuable insight into the pathophysiological implications of SCI on GI function.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No Biospecimens will be collected.
Sampling Method Non-Probability Sample
Study Population SCI and able-bodied individuals, 18-75 years of age
Condition SCI
Intervention Device: SmartPill ingestion and monitoring
The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.
Study Groups/Cohorts
  • Group 1
    SCI
    Intervention: Device: SmartPill ingestion and monitoring
  • Group 2
    Able-bodied
    Intervention: Device: SmartPill ingestion and monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: January 28, 2010)
40
Original Estimated Enrollment
 (submitted: March 5, 2009)
30
Actual Study Completion Date December 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00856648
Other Study ID Numbers B4162C-3
KOR-09-02 ( Other Identifier: James J. Peters VA Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor US Department of Veterans Affairs
Collaborators Not Provided
Investigators
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
PRS Account VA Office of Research and Development
Verification Date May 2012