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

Phase 4

Completed

• Conditions: Constipation
• Interventions: Drug: Lubiprostone

• Registration Number: NCT00844831
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-05
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2011-08-04
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Results First Posted: 2017-07-27
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with lubiprostone	Lubiprostone	Subjects receive lubiprostone and bacteria is measured before and after

Primary Outcome Measures

Name	Time	Method
Presence of Small Intestinal Bacterial Overgrowth	28 days	Percent of patients with bacterial overgrowth before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Small Bowel and Colon Transit Time by SmartPill® Transit Study	28 days
Small Intestinal Bacterial Overgrowth (SIBO)	28 days	SIBO was measured before and after treatment.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States