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

June 28, 2017 updated by: University of Louisville
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Amitiza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Small Intestinal Bacterial Overgrowth
Time Frame: 28 days
Percent of patients with bacterial overgrowth before and after treatment.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small Bowel and Colon Transit Time by SmartPill® Transit Study
Time Frame: 28 days
28 days
Small Intestinal Bacterial Overgrowth (SIBO)
Time Frame: 28 days
SIBO was measured before and after treatment.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Takeda

Investigators

  • Principal Investigator: John Wo, MD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (Estimate)

February 16, 2009

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 285.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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