ConstipationWholeGutNCT00603707
Assessment of Whole Gut Transit Time Using the SmartPill Capsule
An observational study of Constipation, run by The SmartPill Corporation at 8 sites in United States.
Trial summary
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- How many people
- 178 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2006to Jun 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with constipation referred to a tertiary motility center
Who may be able to join
- Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
- Bowel movement frequency of < 3 times per week but at least once per two weeks.
- Constipation symptoms for at least 1 year duration.
- Constipation, not abdominal pain, as the primary symptom.
- Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
- Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.
Who cannot join
- Previous history of bezoars.
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Any abdominal surgery within the past 3 months
- Known or history of inflammatory bowel disease
- History of diverticulitis, diverticular stricture, and other intestinal strictures
- Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
Show all 14Show fewer
- Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
- BMI > 38
- Allergies to components of the SmartBar (Appendix IX).
- Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion).
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
- Any contraindication to use of Fleets Enema or balloon expulsion test.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
VA Medical Center
Buffalo, New York, 14215
University of Iowa
Iowa City, Iowa, 52242
Kansas University Medical Center
Kansas City, Kansas, 66160
Temple University Medical Center
Philadelphia, Pennsylvania, 19140
Mayo Clinic, Scottsdale
Scottsdale, Arizona, 85259
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
Read the detailed description
The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
- Conditions
- Constipation
- Keywords
- capsule, constipation, whole gut transit, colonic transit, gastric emptying, small bowel transit
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | healthy adult subjects with no history or current gastrointestinal disorders or conditions | |
| Constipated | Adult subjects with functional constipation as define by Rome II criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
whole gut transit time
Measured: 2 days and 5 days
Secondary outcomes (1)
Determine regional gut (gastric, small bowel, colonic) transit times
Measured: continuous time measure until caspule elimination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- The SmartPill Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry Parkman, MD, Study chair, Temple University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603707
- Sponsor's protocol ID
- 122205
- Acronym
- WholeGut
- Status last verified
- Aug 2008
- First submitted
- 8 Jan 2008
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study
- ClinicalTrials.gov ID
- NCT00603707
- Acronym / sponsor ID
- WholeGut / 122205
- Conditions
- Constipation
- Keywords
- capsule, constipation, whole gut transit, colonic transit, gastric emptying, small bowel transit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- The SmartPill CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Jan 2008 (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.
Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.
Detailed description
The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.
Both techniques are simultaneously applied in normal and constipated adult populations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –healthy adult subjects with no history or current gastrointestinal disorders or conditions |
| Constipated | – | –Adult subjects with functional constipation as define by Rome II criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with constipation referred to a tertiary motility center
Key inclusion criteria (6 listed)
- Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation
- Bowel movement frequency of < 3 times per week but at least once per two weeks.
- Constipation symptoms for at least 1 year duration.
- Constipation, not abdominal pain, as the primary symptom.
- Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.
Key exclusion criteria (14 listed)
- Previous history of bezoars.
- Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
- Any abdominal surgery within the past 3 months
- Known or history of inflammatory bowel disease
- History of diverticulitis, diverticular stricture, and other intestinal strictures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
whole gut transit time
Time frame: 2 days and 5 days
1 secondary outcome
Determine regional gut (gastric, small bowel, colonic) transit times
Time frame: continuous time measure until caspule elimination
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 29 Aug 2008.
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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.
Henry Parkman, MD study chair
Temple University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by The SmartPill Corporation at 8 sites 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 14 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 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
whole gut transit time (time frame: 2 days and 5 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 29 Aug 2008.