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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Constipation	Drug: Lubiprostone	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
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
Study Start Date :	May 2009
Actual Primary Completion Date :	May 2011
Actual Study Completion Date :	May 2011

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00844831 History of Changes
Other Study ID Numbers:	285.09
First Posted:	February 16, 2009
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