Irritable Bowel SyndromeNCT01162863
Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation
A study testing Lubiprostone and Smartpill wireless motility capsule in people with Irritable Bowel Syndrome and Constipation, run by University of Michigan at 1 site in United States.
Trial summary
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation
- What is being tested?
- Lubiprostone and Smartpill wireless motility capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or females >18 years of age
- Meet Rome III criteria for IBS[2]:
- Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated with 2 or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency
- Onset associated with a change in form (appearance) of stool
Show all 20Show fewer
- *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
- Fulfill the Rome III stool consistency criteria for IBS-C[2]
- Hard or lumpy stools for >25% of bowel movements
- Loose (mushy) or watery stools for <25% of bowel movements
- Capable of independently completing all requirements of the study including returning for required visits
- Able to provide written informed consent for study participation
- Willing to discontinue prohibited medications during study participation
- Documentation of a normal colonoscopy within last 5 years if over age 50 years (or sigmoidoscopy if less than age 50)
- Documentation of normal thyroid stimulating hormone(TSH) level, complet blood count (CBC) and electrolyte panel within prior 3 years
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening
- Females of childbearing potential must use an effective means of contraception during the course of the study
- Hormonal (oral, injectable, implantable, cervical/vaginal rings or patches)
- Double-barrier (condoms and/or diaphragm with spermicides) or intrauterine devices provided under the care of a health care professional
- Abstinence, in this case documentation of counseling will be recorded
Who cannot join
- Unable to understand or provide written informed consent
- Pregnant or nursing
- Patients with IBS-D, IBS-M or unsubtyped IBS by Rome III criteria[2]
- IBS with diarrhea (IBS-D)
- Loose (mushy) or watery stools for >25% of bowel movements
- Hard or lumpy stools for <25% of bowel movements
Show all 59Show fewer
- Mixed IBS (IBS-M)
- Hard or lumpy stools >25% of bowel movements
- Loose (mushy) or watery stools for >25% of bowel movements
- Unsubtyped IBS
- 1. Insufficient abnormality of stool pattern to meet criteria for IBS-C, IBS-D or IBS-M
- Documented allergy or intolerance to lubiprostone
- Failure of balloon expulsion test
- Inability to expel 50cc balloon within 1 minute
- Use of drugs known to affect gastrointestinal motility
- Laxatives (stable doses of fiber taken for minimum of 4 weeks will be allowed)
- Osmotic laxatives:
- Magnesium hydroxide, Polyethylene glycol,Lactulose, Sorbitol
- Stimulant laxatives:
- Bisacodyl, Anthraquinones (senna), Misoprostol
- Prokinetic agents:
- Metoclopramide, domperidone, erythromycin
- Anti-diarrheal agents:
- Loperamide, Diphenoxylate, Bismuth
- Anti-spasmotics:
- Dicyclomine, Hyoscyamine
- Opioid, narcotic, opioid/narcotic-containing analgesics:
- Morphine, Hydrocodone, Codeine, Methadone, Propoxyphene
- Probiotics
- Systemic antibiotics within last 3 months
- Recently initiated antidepressants (stable dose for >2 months for non-GI conditions will be allowed)
- Benzodiazepines * Subjects taking prohibited medications will be required to stop these at the screening visit and remain off of them until completion of the study.
- Initiation of dietary changes potentially altering bowel transit within 4 weeks
- Comorbid medical problems that may affect gastrointestinal transit or motility
- Previous surgery involving the stomach, small bowel or colon (prior appendectomy, cholecystectomy, polypectomy allowed)
- Previous history of small bowel obstruction for any reason
- History of any gastrointestinal malignancy
- History of dyssynergic defecation
- Unexplained nausea and vomiting
- History of inflammatory bowel disease (Crohn's or ulcerative colitis)
- History of microscopic colitis (lymphocytic or collagenous colitis)
- History of Hirschsprung's disease
- Severe or complicated diverticular disease
- Chronic pancreatitis
- History of celiac disease
- History of eating disorders (anorexia nervosa or bulimia)
- Cirrhosis
- Chronic hepatitis B or C infection
- HIV infection
- Diabetes
- Systemic sclerosis (scleroderma)
- Amyloidosis
- Untreated thyroid disease
- Chronic pulmonary disease
- Severe renal insufficiency or renal failure
- Current or recent history (within last 6 months) of:
- Diverticulitis, Duodenal or gastric ulcer, Acute pancreatitis, Ileus
- Contraindications to SmartPill® (in addition to above):
- Cardiac pacemaker, defibrillator, or other implanted electromagnetic device, Known Zenker's diverticulum, Dysphagia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48103
About this study
Official title: A Pilot Study to Assess the Effects of Lubiprostone on Gastrointestinal and Colonic Motility and pH in Patients With the Irritable Bowel Syndrome and Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility.
Lubiprostone, a novel drug that works by activating the colonic Chloride channel type 2(ClC-2), has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms.
Read more
The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit time.
The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone.
The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.
- Conditions
- Irritable Bowel Syndrome, Constipation
- Being tested
- Lubiprostone, Placebo, Smartpill wireless motility capsule
- Keywords
- IBSC, irritable bowel syndrome, constipation
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LubiprostoneDrug
lubiprostone taken either at a dose of 8 mcg orally twice daily (BID) for 28 days or 24 mcg orally once daily (QD) for 28 days
PlaceboDrug
taken orally for 28 days
Smartpill wireless motility capsuleOther
Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
| Study group | Role | What they receive |
|---|---|---|
| Lubiprostone 8 mcg BID | Active comparator | Not described Receives: Drug: Lubiprostone; Other: Smartpill wireless motility capsule |
| Lubiprostone 24 mcg QD | Active comparator | Not described Receives: Drug: Lubiprostone; Other: Smartpill wireless motility capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Smartpill wireless motility capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm
Measured: 21-28 days
Secondary outcomes (2)
Change in Small Bowel pH and Colon pH From Baseline
Change in the mean pH of the small intestine and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.
Measured: 21-28 days
Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index
Change in the motility index defined as the natural log [(sum of pressure amplitudes times the number of contractions) + 1] for the small bowel and colon based on a measurement done at baseline and then again at 3 weeks into the intervention.
Measured: 21-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Richard J. Saad, M.D., University of Michigan
- Investigators
- Richard Saad, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162863
- Sponsor's protocol ID
- 08-028LUB
- Status last verified
- Dec 2016
- First submitted
- 9 Jul 2010
- Last updated
- 27 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Effects of Lubiprostone on Gastrointestinal and Colonic Motility and pH in Patients With the Irritable Bowel Syndrome and Constipation (IBS-C)
- ClinicalTrials.gov ID
- NCT01162863
- Acronym / sponsor ID
- 08-028LUB
- Conditions
- Irritable Bowel Syndrome, Constipation
- Keywords
- IBSC, irritable bowel syndrome, constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals North America, Inc.
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Posted 27 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility.
Lubiprostone, a novel drug that works by activating the colonic Chloride channel type 2(ClC-2), has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms.
The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit time.
The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone.
The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lubiprostone 8 mcg BID | Active comparator | Drug: Lubiprostone, Other: Smartpill wireless motility capsule |
| Lubiprostone 24 mcg QD | Active comparator | Drug: Lubiprostone, Other: Smartpill wireless motility capsule |
| Placebo | Placebo comparator | Drug: Placebo, Other: Smartpill wireless motility capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males or females >18 years of age
- Meet Rome III criteria for IBS[2]:
- Fulfill the Rome III stool consistency criteria for IBS-C[2]
- Capable of independently completing all requirements of the study including returning for required visits
- Able to provide written informed consent for study participation
Key exclusion criteria (59 listed)
- Unable to understand or provide written informed consent
- Pregnant or nursing
- Patients with IBS-D, IBS-M or unsubtyped IBS by Rome III criteria[2]
- IBS with diarrhea (IBS-D)
- Mixed IBS (IBS-M)
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 |
|---|---|---|
| Lubiprostonelubiprostone taken either at a dose of 8 mcg orally twice daily (BID) for 28 days or 24 mcg orally once daily (QD) for 28 days | Drug | Lubiprostone 24 mcg QD, Lubiprostone 8 mcg BID |
| Placebotaken orally for 28 days | Drug | Placebo |
| Smartpill wireless motility capsuleIngestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus | Other | Lubiprostone 24 mcg QD, Lubiprostone 8 mcg BID, Placebo |
Primary outcome
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline
Time frame: 21-28 days
Change in gastric emptying time, small bowel transit time, colon transit time and whole gut transit time measured in hours based on a measurement done at baseline and then again at 3 weeks into the intervention within each treatment arm
2 secondary outcomes
Change in Small Bowel pH and Colon pH From Baseline
Time frame: 21-28 days
Change in Motility Pattern of the Small Bowel and Colon From Baseline as Defined by the Motility Index
Time frame: 21-28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Richard Saad principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubiprostone and Smartpill wireless motility capsule in people with Irritable Bowel Syndrome and Constipation, run by University of Michigan 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 20 inclusion and 59 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 27 Jan 2017. 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. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Gastric Emptying Time, Small Bowel Transit Time, Colon Transit Time and Whole Gut Transit Time From Baseline (time frame: 21-28 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 27 Jan 2017.