Irritable Bowel SyndromeNCT01114113
Assessment of Gastric Emptying Speed in Patients Who Experience Diarrhea Following a Trigger Meal
A study testing SmartPill capsule in people with Irritable Bowel Syndrome and Diarrhea, run by Money, Mary E., M.D..
Trial summary
The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Diarrhea
- What is being tested?
- SmartPill capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jan 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
- The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
- In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
- The patient must be willing to comply with all of the study protocol.
Who cannot join
- The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
- The patient has nocturnal bowel movements.
- The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
- The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
- Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
- The patient reports daily use of laxatives or stool softeners; use of fiber supplementation is permitted.
Show all 15Show fewer
- The patient is currently using pancrealipase. Previous use of pancrealipase in the past is allowed, but patients must be off either of the medication for at least 1 week or until the patient's symptoms of post prandial diarrhea returns before participating in the study.
- Use of implanted or ambulatory electromechanical medical devices such as pacemakers, insulin pumps, and infusion pumps.
- History of gastroparesis or chronic use of reglan.
- Dysphagia to solid food and pills.
- Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass or ulcer surgery.
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- BMI > 35
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
About this study
Official title: Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea
The rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance". Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.
Read the detailed description
Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times. Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo. Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study. Willing participants will receive a small stipend each time they swallow the radio frequency capsule. This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.
- Conditions
- Irritable Bowel Syndrome, Diarrhea
- Being tested
- pancelipase/placebo, SmartPill capsule
- Keywords
- IBS-D, Post meal Diarrhea, Trigger meals
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancelipase/placeboDrug
ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule.
SmartPill capsuleDevice
Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
SmartPill capsuleDevice
Measurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule
SmartPill capsuleDevice
SmartPill capsule
| Study group | Role | What they receive |
|---|---|---|
| non-trigger meal | Active comparator | Measurement of intestinal transport eating a "non-trigger meal". Receives: Device: SmartPill capsule |
| "trigger meal baseline" | Active comparator | Measurement of intestinal transport after eating a "trigger meal". Receives: Device: SmartPill capsule |
| "trigger meal" with placebo | Placebo comparator | Measurement of intestinal transport with blinded placebo Receives: Drug: pancelipase/placebo; Device: SmartPill capsule |
| "trigger meal" with enzymes (blinded) | Active comparator | Measurement of intestinal transport with blinded active enzyme capsule Receives: Drug: pancelipase/placebo; Device: SmartPill capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo.
Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.
Measured: 72 hour measurement per meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Lack of interest in participation by patients locally and lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Money, Mary E., M.D.
- Responsible party
- Principal investigator, Mary E. Money, M.D., Money, Mary E., M.D.
- Investigators
- Mary E Money, M.D., Principal investigator, Washington County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114113
- Sponsor's protocol ID
- 2010IBS-G/D eval
- Status last verified
- Apr 2012
- First submitted
- 25 Apr 2010
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Money ME, Hofmann AF, Hagey LR, Walkowiak J, Talley NJ. Treatment of irritable bowel syndrome-diarrhea with pancrealipase or colesevelam and association with steatorrhea. Pancreas. 2009 Mar;38(2):232-3. doi: 10.1097/MPA.0b013e31817c1b36. No abstract available.
PubMed 19238028
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Assessment of Gastric and Intestinal Motility Following a Trigger Meal in Patients With Post Prandial Diarrhea
- ClinicalTrials.gov ID
- NCT01114113
- Acronym / sponsor ID
- 2010IBS-G/D eval
- Conditions
- Irritable Bowel Syndrome, Diarrhea
- Keywords
- IBS-D, Post meal Diarrhea, Trigger meals
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest in participation by patients locally and lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Money, Mary E., M.D.
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Apr 2010 (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 rapid diarrhea that patients experience who have diarrhea occurring after eating specific foods may be causing a "physiologic gastric dumping syndrome". This means that rather than the food being kept in the stomach for normal digestion, it rapidly goes into the small intestine and diarrhea occurs. This study is designed to measure how fast the food empties from the stomach when a person with this problem consumes a "regular diet", compared to a meal with a "triggering substance". Each participant will swallow a radio frequency capsule that with the different meals that will show how fast the food is traveling through the intestines in the different situations.
Detailed description
Since some patients have found that pancreatic enzymes seem to ameliorate this diarrhea from occurring,willing participants will be asked to duplicate the "triggering meal" 2 more times. Once taking a pancreatic enzyme (active drug) with the meal and a second time taking an identical placebo. Neither the participant nor the study investigator will know which capsule is the active drug in this phase of the study. Willing participants will receive a small stipend each time they swallow the radio frequency capsule. This capsule is large, approximately twice the size of a vitamin pill so individuals must have no difficulties with swallow to participate nor any history of bowel obstruction or major surgery to the abdominal which might have caused adhesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-trigger meal | Active comparator | Device: SmartPill capsuleMeasurement of intestinal transport eating a "non-trigger meal". |
| "trigger meal baseline" | Active comparator | Device: SmartPill capsuleMeasurement of intestinal transport after eating a "trigger meal". |
| "trigger meal" with placebo | Placebo comparator | Drug: pancelipase/placebo, Device: SmartPill capsuleMeasurement of intestinal transport with blinded placebo |
| "trigger meal" with enzymes (blinded) | Active comparator | Drug: pancelipase/placebo, Device: SmartPill capsuleMeasurement of intestinal transport with blinded active enzyme capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have been diagnosed as having post prandial diarrhea for at least 5 years by his/her primary care physician or gastroenterologist and is believed to have no other medical condition that would cause this medical problem. Each person must be over 18 years old and have negative testing for Celiac Disease, a normal colonoscopy within 5 years of enrollment, and a normal Hgb and sedimentation rate within 6 months of enrollment in the trial.
- The patient has provided documented written informed consent/authorization prior to initiation of any study-related procedure.
- In addition, each patient must report experiencing the onset of urgent defecation within 1 hours of eating a specific trigger which is reproducible at least 90% of the time when consume.
- The patient must be willing to comply with all of the study protocol.
Key exclusion criteria (15 listed)
- The patient has had any rectal bleeding or bloody stools within the last 2 years not completely evaluated by a physician. If rectal bleeding has occurred, and the patient wants to be considered for the study, the diagnostic workup must have clearly identified the etiology for the bleeding and excluded the medical conditions listed under 3 below. The patient must be willing to allow the Study team to obtain these records for verification of the diagnosis.
- The patient has nocturnal bowel movements.
- The patient has been diagnosed with or has a family history of any of the following: ulcerative colitis, Crohn's Disease, celiac disease, sprue, other inflammatory bowel disease or has a positive test for celiac disease on screening lab and has not had a full investigation performed to exclude celiac disease.
- The patient has had unexplained anorexia or weight loss of more than 10% of body weight within 12 months of onset of study.
- Prior GI surgery except of uncomplicated appendectomy and laparoscopic cholecystectomy or history of bowel obstruction or symptoms suggestive of such within the past 2 years.
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 |
|---|---|---|
| pancelipase/placeboZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical "trigger meals" and will not be given for the initial baseline "non-trigger" and baseline "trigger meal". In both of these arms, patients will also be swallowing the SmartPill Capsule. | Drug | "trigger meal" with enzymes (blinded), "trigger meal" with placebo |
| SmartPill capsuleMeasurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule. | Device | non-trigger meal |
| SmartPill capsuleMeasurement of intestinal transit of a "trigger meal" baseline by using the SmartPill capsule | Device | "trigger meal baseline" |
| SmartPill capsuleSmartPill capsule | Device | "trigger meal" with enzymes (blinded), "trigger meal" with placebo |
Primary outcome
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo.
Time frame: 72 hour measurement per meal
Data from the SmartPill radiofrequency capsule that is swallowed at the beginning of the different meals will be recorded and compared.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Background: PubMed 19238028Money ME, Hofmann AF, Hagey LR, Walkowiak J, Talley NJ. Treatment of irritable bowel syndrome-diarrhea with pancrealipase or colesevelam and association with steatorrhea. Pancreas. 2009 Mar;38(2):232-3. doi: 10.1097/MPA.0b013e31817c1b36. No abstract available.
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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.
Mary E Money, M.D. principal investigator
Washington County Hospital
Questions about this trial
What is this clinical trial studying?
A study testing SmartPill capsule in people with Irritable Bowel Syndrome and Diarrhea, run by Money, Mary E., M.D..
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 4 inclusion and 15 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: withdrawn, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Duration of intestinal speed of a "trigger meal" compared to a non-trigger meal baseline. Optional study comparing intestinal speed of trigger meal using Pancrelipase compared to placebo. (time frame: 72 hour measurement per meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01114113, which also lists 1 linked publication.
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 20 Apr 2012.