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

Study Overview
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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.

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.

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

Conditions
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Constipation

Intervention / Treatment
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* Drug: Lubiprostone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with lubiprostone<br>Subjects receive lubiprostone and bacteria is measured before and after | Drug: Lubiprostone<br>* 24 mcg bid for 28 days<br>* Other names: Amitiza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Small Intestinal Bacterial Overgrowth | 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 |  | 28 days | 
| Small Intestinal Bacterial Overgrowth (SIBO) | SIBO was measured before and after treatment. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, small intestinal bacterial overgrowth, stool bacteria