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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, small intestinal bacterial overgrowth, stool bacteria

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with lubiprostone

Arm Description

Subjects receive lubiprostone and bacteria is measured before and after

Outcomes

Primary Outcome Measures

Presence of Small Intestinal Bacterial Overgrowth
Percent of patients with bacterial overgrowth before and after treatment.

Secondary Outcome Measures

Small Bowel and Colon Transit Time by SmartPill® Transit Study
Small Intestinal Bacterial Overgrowth (SIBO)
SIBO was measured before and after treatment.

Full Information

First Posted
February 13, 2009
Last Updated
June 28, 2017
Sponsor
University of Louisville
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00844831
Brief Title
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Official Title
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, small intestinal bacterial overgrowth, stool bacteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with lubiprostone
Arm Type
Experimental
Arm Description
Subjects receive lubiprostone and bacteria is measured before and after
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
24 mcg bid for 28 days
Primary Outcome Measure Information:
Title
Presence of Small Intestinal Bacterial Overgrowth
Description
Percent of patients with bacterial overgrowth before and after treatment.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Small Bowel and Colon Transit Time by SmartPill® Transit Study
Time Frame
28 days
Title
Small Intestinal Bacterial Overgrowth (SIBO)
Description
SIBO was measured before and after treatment.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Wo, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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

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