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

This study has been completed.

Sponsor:

Collaborator:

Takeda

Information provided by (Responsible Party):

University of Louisville

ClinicalTrials.gov Identifier:

NCT00844831

First received: February 13, 2009

Last updated: June 28, 2017

Last verified: June 2017

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:	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:

MedlinePlus related topics: Constipation

Drug Information available for: Lubiprostone

U.S. FDA Resources

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


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:

History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
History of gastric outlet, small bowel, or colon obstruction
History of surgery for small bowel adhesion lysis
History of surgery for gastroparesis
Diagnosis of diabetes requiring daily medications
Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
Disorders of small bowel pseudo-obstruction or dumping syndrome
Untreated or poorly controlled hypothyroidism
Taking an opiate medication daily
Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
Active cancer being treated
History of significant liver, kidney, cardiac disease that may interfere with study compliance
Known allergy or side effects to lubiprostone
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


Responsible Party:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00844831 History of Changes
Other Study ID Numbers:	285.09
Study First Received:	February 13, 2009
Results First Received:	August 4, 2011
Last Updated:	June 28, 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

ClinicalTrials.gov processed this record on August 18, 2017

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