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
About this trial
This is an interventional treatment trial for Constipation focused on measuring Constipation, small intestinal bacterial overgrowth, stool bacteria
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.
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
NCT ID
NCT00844831
First Posted
February 13, 2009
Last Updated
June 28, 2017
Sponsor
University of Louisville
Collaborators
Takeda
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
Learn more about this trial
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
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