Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00856648 |
| Other study ID # |
B4162C-3 |
| Secondary ID |
KOR-09-02 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 4, 2009 |
| Last updated |
May 21, 2012 |
| Start date |
April 2009 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
May 2012 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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.
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.
