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

NCT00844831 | Completed Phase 4 Results

• 1 other identifier: 285.09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation

Keywords

Constipation; small intestinal bacterial overgrowth; stool bacteria

Outcome Measures

Primary Outcomes (1)

• Presence of Small Intestinal Bacterial Overgrowth

  Percent of patients with bacterial overgrowth before and after treatment.

  28 days

Secondary Outcomes (2)

• Small Bowel and Colon Transit Time by SmartPill® Transit Study

  28 days

• Small Intestinal Bacterial Overgrowth (SIBO)

  28 days

Study Arms (1)

Treatment with lubiprostone

EXPERIMENTAL

Subjects receive lubiprostone and bacteria is measured before and after

Drug: Lubiprostone

Interventions

Lubiprostone DRUG

24 mcg bid for 28 days

Also known as: Amitiza

Treatment with lubiprostone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Takeda: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: John M. Wo, MD
• Organization: University of Louisville

johnwogi@gmail.com

502-852-6991

Study Officials

• John Wo, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-06

Locations

US (1)