SCINCT00856648
SmartPill Monitoring for Assessment of GI Function in SCI
An observational study of SCI, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI
- What is being tested?
- SmartPill ingestion and monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SCI and able-bodied individuals, 18-75 years of age
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- SCI
- Being tested
- SmartPill ingestion and monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartPill ingestion and monitoringDevice
The SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | SCI Receives: Device: SmartPill ingestion and monitoring | |
| Group 2 | Able-bodied Receives: Device: SmartPill ingestion and monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic transit time (CTT)
Measured: 1-4 days
Secondary outcomes (2)
Total transit time (TTT)
Measured: 1-4 days
Gastric emptying time (GET)
Measured: 1-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark A. Korsten, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856648
- Sponsor's protocol ID
- B4162C-3
- Other IDs
- KOR-09-02
- Status last verified
- May 2012
- First submitted
- 4 Mar 2009
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartPill Monitoring for Assessment of GI Function in SCI
- ClinicalTrials.gov ID
- NCT00856648
- Acronym / sponsor ID
- B4162C-3
- Conditions
- SCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: SmartPill ingestion and monitoringSCI |
| Group 2 | – | Device: SmartPill ingestion and monitoringAble-bodied |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SCI and able-bodied individuals, 18-75 years of age
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Inadequately managed complications related to SCI
- Evidence of bowel obstruction
- Evidence of inflammatory bowel disease
- History of cerebral palsy or cerebral apoplexy
- Multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartPill ingestion and monitoringThe SmartPill device will be ingested and remotely monitored until it is excreted in a normal bowel movement. | Device | Group 1, Group 2 |
Primary outcome
Colonic transit time (CTT)
Time frame: 1-4 days
2 secondary outcomes
Total transit time (TTT)
Time frame: 1-4 days
Gastric emptying time (GET)
Time frame: 1-10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A. Korsten, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCI, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic transit time (CTT) (time frame: 1-4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.