Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Louisville.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Takeda
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00844831
First received: February 13, 2009
Last updated: June 21, 2010
Last verified: April 2009
History of Changes
  Purpose

Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.


Condition Intervention Phase
Constipation
 Drug: Lubiprostone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Compare before and after treatment with lubiprostone 24 mcg bid: presence of small intestinal bacterial overgrowth and quantitative amount and proportion of each bacteria species by stool DNA polymerase chain reaction. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare before and after treatment with lubiprostone 24 mcg bid: small bowel and colon transit time by SmartPill® transit study [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lubiprostone
    24 mcg bid for 28 days
    Other Name: Amitiza
Detailed Description:

This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Functional constipation by Rome III criteria

Exclusion Criteria:

  1. History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
  2. History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
  3. History of gastric outlet, small bowel, or colon obstruction
  4. History of surgery for small bowel adhesion lysis
  5. History of surgery for gastroparesis
  6. Diagnosis of diabetes requiring daily medications
  7. Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
  8. Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
  9. Disorders of small bowel pseudo-obstruction or dumping syndrome
  10. Untreated or poorly controlled hypothyroidism
  11. Taking an opiate medication daily
  12. Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
  13. Active cancer being treated
  14. History of significant liver, kidney, cardiac disease that may interfere with study compliance
  15. Known allergy or side effects to lubiprostone
  16. Non-ambulatory patients: bed-ridden, nursing home resident, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844831

Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Takeda
Investigators
Principal Investigator: John Wo, MD University of Louisville
  More Information

No publications provided

Responsible Party: John M. Wo, M.D., University of Louisville
ClinicalTrials.gov Identifier: NCT00844831     History of Changes
Other Study ID Numbers: 285.09
Study First Received: February 13, 2009
Last Updated: June 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Constipation
small intestinal bacterial overgrowth
stool bacteria

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on February 27, 2015