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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with lubiprostone

Subjects receive lubiprostone and bacteria is measured before and after

Group Type EXPERIMENTAL

Lubiprostone

Intervention Type DRUG

24 mcg bid for 28 days

Interventions

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Lubiprostone

24 mcg bid for 28 days

Intervention Type DRUG

Other Intervention Names

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Amitiza

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No