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OpenTrials
Completed

NCT Number: NCT00844831

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lubiprostone

Drug

24 mcg bid for 28 days

Other names: Amitiza

Primary outcomes

  1. Presence of Small Intestinal Bacterial Overgrowth

    Time frame: 28 days

    Percent of patients with bacterial overgrowth before and after treatment.

Secondary outcomes

  1. Small Bowel and Colon Transit Time by SmartPill® Transit Study

    Time frame: 28 days

  2. Small Intestinal Bacterial Overgrowth (SIBO)

    Time frame: 28 days

    SIBO was measured before and after treatment.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 16, 2009
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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