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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00844831
First Posted: February 16, 2009
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
University of Louisville
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Presence of Small Intestinal Bacterial Overgrowth [ Time Frame: 28 days ]
    Percent of patients with bacterial overgrowth before and after treatment.


Secondary Outcome Measures:
  • Small Bowel and Colon Transit Time by SmartPill® Transit Study [ Time Frame: 28 days ]
  • Small Intestinal Bacterial Overgrowth (SIBO) [ Time Frame: 28 days ]
    SIBO was measured before and after treatment.


Enrollment: 25
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with lubiprostone
Subjects receive lubiprostone and bacteria is measured before and after
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00844831     History of Changes
Other Study ID Numbers: 285.09
First Submitted: February 13, 2009
First Posted: February 16, 2009
Results First Submitted: August 4, 2011
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

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

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action