Phase 4
N=25
Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00844831 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Jul 2017
Primary outcome: Primary: Presence of Small Intestinal Bacterial Overgrowth — 8; 9 Participants — p=0.75
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lubiprostone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Small Intestinal Bacterial Overgrowth |
8; 9 | 0.75 |
| SECONDARY Small Bowel and Colon Transit Time by SmartPill® Transit Study |
— | — |
| SECONDARY Small Intestinal Bacterial Overgrowth (SIBO) |
8; 9 | .9 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00844831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.