Intestinal Microecology in Chronic Constipation

NCT00934479 | Completed Phase 1

• 1 other identifier: 09-001281
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the bacteria normally present in the bowels are different in people with constipation and to see what effect the treatment with the Food and Drug Administration (FDA) - approved drug, lubiprostone, has on these bacteria.

Conditions

Other Constipation; Irritable Bowel Syndrome

Keywords

Chronic Constipation; Constipation Predominant Irritable Bowel Syndrome; Intestinal Microecology

Outcome Measures

Primary Outcomes (1)

• Identification of specific microorganisms associated with chronic constipation in comparison to healthy subjects and those with C-IBS

  5 weeks

Secondary Outcomes (1)

• Evaluate changes in the gut microbiota after lubiprostone treatment in the chronic constipation subjects and those with C-IBS

  5 weeks

Study Arms (2)

Healthy Subjects

NO INTERVENTION

Healthy subjects completed a baseline 1-week diary of stool and defecatory characteristics, fasting breath for hydrogen and methane and a stool sample for pyrosequencing. Otherwise, the healthy subjects received no intervention.

Constipated Subjects

EXPERIMENTAL

Subjects with constipation included those with chronic constipation (CC) and those with constipation predominant irritable bowel syndrome (C-IBS). They completed a baseline 1-week diary of stool and defecatory characteristics, fasting breath for hydrogen and methane and a stool sample for pyrosequencing. Following baseline test and because of differences in the FDA-approved dosing for the 2 subtypes of chronic constipation, the CC subjects received open-label lubiprostone 24 mcg orally twice daily for 4 weeks; while the C-IBS subjects received open-label lubiprostone 8 mcg orally twice daily for 4 weeks. Following the 4-weeks treatment with lubiprostone, they completed another stool diary, fasting breath test, and stool sample for pyrosequencing.

Drug: Lubiprostone

Interventions

Lubiprostone DRUG

Following the initial stool and breath collections and because of differences in the FDA-approved dosing for the 2 subtypes of chronic constipation, (that is, chronic constipation (CC) versus constipation due to irritable bowel syndrome (C-IBS), the CC subjects received open-label lubiprostone 24 mcg orally twice daily for 4 weeks; while the C-IBS subjects received open-label lubiprostone 8 mcg orally twice daily for 4 weeks.

Also known as: Amitiza

Constipated Subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fewer than 3 bowel movements/day and more than 3 bowel movements/week without the need for significant straining with defecation or frequent sensation of incomplete evacuation after defecation
• Absence of current or chronic gastrointestinal symptoms
• Meet Rome III criteria for chronic functional constipation
• Colonoscopy within the previous 10 years for subjects ≥ 50 years of age
• Meet Rome III criteria for C-IBS
• Colonoscopy within the previous 10 years for subjects ≥ 50 years of age

You may not qualify if:

• Prior gastrointestinal surgery that altered the anatomy of the esophagus, stomach, or small/large intestine (exceptions include appendectomy and cholecystectomy)
• Gastrointestinal, cardiovascular, endocrine, renal, or other chronic disease likely to affect gastrointestinal motility (e.g., uncontrolled diabetes mellitus)
• Females of childbearing age who are not practicing birth control and/or are pregnant or lactating (a urine pregnancy test will be performed on female subjects prior to lubiprostone use)
• Significant untreated psychiatric disease
• History of hypersensitivity reaction or intolerance to lubiprostone
• Inability to stop antibiotics, probiotics, and fiber supplements 1 month prior to stool sample collection
• Inability to stop proton pump inhibitors, histamine 2 receptor antagonists, prokinetic agents, narcotic analgesic agents, laxatives, and anticholinergic agents 2 weeks prior to stool sample collection

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona State University: collaborator
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• Kang DW, DiBaise JK, Ilhan ZE, Crowell MD, Rideout JR, Caporaso JG, Rittmann BE, Krajmalnik-Brown R. Gut microbial and short-chain fatty acid profiles in adults with chronic constipation before and after treatment with lubiprostone. Anaerobe. 2015 Jun;33:33-41. doi: 10.1016/j.anaerobe.2015.01.005. Epub 2015 Jan 21.

  PMID: 25617726 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• John K. DiBaise, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: April 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

US (1)