Status:
COMPLETED
Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Chronic Constipation, Methanogenesis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether Lubiprostone has effects ...
Eligibility Criteria
Inclusion
- Constipation as defined by Rome III criteria13. Patients must have symptoms \> 3 days/month for the past three months and report at least two of the following symptoms ≥ 25% of the time: straining, lumpy or hard stool, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage, use of manual maneuvers, \< 3 bowel movements/week. Also,they should have insufficient criteria for IBS, and only rarely loose stools without the use of laxatives.
- ≥ 3 ppm methane value at baseline1, 2(before sugar load).
Exclusion
- Patients taking drugs that are known to be constipating will be excluded or asked to discontinue medications for at least 2 weeks and reassessed. For example, we will recommend that patients taking calcium channel antagonists contact their respective primary care physicians to explore alternative medications for hypertension such as beta blockers or ACE-inhibitors. If the calcium channel antagonists are able to be discontinued, patients will be re-screened at least two weeks after the medications are discontinued. If patients no longer meet inclusion criteria, they will be excluded from the study. Patients who remain constipated will be eligible for enrollment.
- Patients with co-morbid illnesses such as severe cardiovascular disease, chronic renal failure, or those with previous gastrointestinal surgery except cholecystectomy and appendectomy
- Patients with neurologic diseases such as multiple sclerosis, strokes, spinal cord injuries, and those who have problems with cognizance, i.e. a mini-mental score of \<15 and/or are legally blind will be excluded.
- Women who are pregnant or are likely to conceive during the course of the study will be excluded. Urinary pregnancy tests will be performed on all women of child-bearing potential prior to enrollment and before any x-ray of the abdomen.
- Patients with Hirschsprung' s disease, or active local anorectal problems such as anal fissures, bleeding hemorrhoids, Crohn's, colitis, or colon cancer.
- Patients with alternating constipation and diarrhea and those who fulfill the Rome-III criteria for irritable bowel syndrome.
- Recent antibiotic use (last 6 weeks).
- Patients using laxatives, PEG or Tegaserod and unwilling to discontinue these medications at least 2 weeks prior to the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01190020
Start Date
February 1 2009
End Date
March 1 2012
Last Update
January 15 2019
Active Locations (2)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
2
University of Utah
Salt Lake City, Utah, United States, 84112