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

University of Louisville (UOFL)

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Lubiprostone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00844831

285.09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment with lubiprostone

Experimental group

Description:

Subjects receive lubiprostone and bacteria is measured before and after

Treatment:

Drug: Lubiprostone