This trial is active, not recruiting.

Condition constipation
Treatment lubiprostone
Phase phase 4
Sponsor University of Louisville
Collaborator Takeda
Start date May 2009
End date September 2010
Trial size 20 participants
Trial identifier NCT00844831, 285.09


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Compare before and after treatment with lubiprostone 24 mcg bid: presence of small intestinal bacterial overgrowth and quantitative amount and proportion of each bacteria species by stool DNA polymerase chain reaction.
time frame: 28 days

Secondary Outcomes

Compare before and after treatment with lubiprostone 24 mcg bid: small bowel and colon transit time by SmartPill® transit study
time frame: 28 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Principal investigator John Wo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Louisville.