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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00844831
• Other study ID #: 285.09
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 13, 2009
• Last updated: June 21, 2010
• Start date: May 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2009
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Lubiprostone
24 mcg bid for 28 days

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28 days	No
Secondary	Compare before and after treatment with lubiprostone 24 mcg bid: small bowel and colon transit time by SmartPill® transit study		28 days	No