Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

• ClinicalTrials.gov Identifier: NCT01469819
• Recruitment Status: Completed
• First Posted: November 10, 2011
• Results First Posted: August 1, 2016
• Last Update Posted: June 9, 2017
• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Information provided by (Responsible Party): Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso

Study Description

Brief Summary:

The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower due to constipation.

To be able to measure the time difference in the duration of transit of the FDA approved SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure to lubiprostone.

The investigators anticipate to capture the possibility to reduce/eliminate the small intestinal bacterial overgrowth in chronically constipated patients after administration of study drug- lubiprostone.

Condition or disease	Intervention/treatment	Phase
Chronic Idiopathic Constipation	Drug: Lubiprostone	Phase 2; Phase 3

Detailed Description:

Lubiprostone is an effective treatment for chronic constipation. The mechanism of action of lubiprostone is through increasing fluid and mucus secretion and improving lubrication of the intestinal lumen. The effects of lubiprostone on gastrointestinal (GI) transit and small bacterial overgrowth (SIBO) have not been sufficiently explored.

The current study was designed to investigate whether: (a) lubiprostone alters GI transit and (b) affects SIBO in constipated patients.

Twenty nine female patients (mean age of 39 year: range 19-64) with chronic constipation received 2 weeks of lubiprostone (24 mcg b.i.d., P.O.). Stool consistency based on Bristol stool scale and the frequency of bowel movements were recorded. Gastric emptying time (GET), small bowel transit time (SBTT), colon transit time (CTT), combined small & large bowel transit time (SLBTT) and whole gut transit time (WGT) were measured using wireless motility capsule. Small bacterial overgrowth (SIBO) status was assessed by the lactulose breath test.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation
• Study Start Date: June 2012
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: February 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lubiprostone; Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.	Drug: Lubiprostone; 24 mcg twice a day (BID) for 2 weeks.; Other Name: Amitiza

Outcome Measures

Primary Outcome Measures :

1. Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
   The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.

Secondary Outcome Measures :

1. Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID). [ Time Frame: Measured at baseline and 2 weeks after baseline ]
2. Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
   Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.
3. Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]
4. Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. [ Time Frame: Measured at baseline and 2 weeks after baseline. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 18-65 years old

• At least a 6 months history of constipation. Constipation defined as follows:

  • Less than three complete spontaneous bowel movements per week and one or more of the following:

    1. At least 25% of stools are very hard and/or hard stools
    2. Sensation of incomplete evacuation following at least 25% of bowel movements.
    3. Straining on at least 25% of defecations. The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study.
• For patients ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy, double-contrast barium enema, or flexible sigmoidoscopy performed within the previous 5 years.

Exclusion Criteria:

• Pregnancy or lactation.
• Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after the study termination.
• Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents).

• Use of any of the following drugs within 3 days prior to randomization:

  • Prokinetic agents (tegaserod, domperidone, cisapride, metoclopramide, erythromycin).
  • Medication containing opiates.
  • Anti-spasmodic (e.g., atropine, hyoscyamine, scopolamine, glycopyrrolate).
• Use of illegal drugs
• Regular consumption of 2 drinks of alcohol per day.
• Chronic nonsteroidal antiinflammatory drugs (NSAIDs) use
• Chronic use of H2 receptor antagonist or proton pump inhibitors (PPIs) within 14 days prior to screening.
• History of gastric or duodenal ulcer, inflammatory bowel disease(IBD), or chronic non-ulcer dyspepsia.
• Diabetes Mellitus (DM) type 1, Parkinson's disease.
• Existence of any medical condition that requires chronic therapy.
• Positive H. pylori serology
• Chronic active diverticulosis

Contacts and Locations

Locations

United States, Texas

Texas Tech University Health Sciences Center

El Paso, Texas, United States, 79905

Sponsors and Collaborators

Texas Tech University Health Sciences Center, El Paso

Takeda Pharmaceuticals North America, Inc.

Investigators

• Principal Investigator: Irene Sarosiek, MD; Texas Tech University Health Sciences Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sarosiek I, Bashashati M, Alvarez A, Hall M, Shankar N, Gomez Y, McCallum RW, Sarosiek J. Lubiprostone Accelerates Intestinal Transit and Alleviates Small Intestinal Bacterial Overgrowth in Patients With Chronic Constipation. Am J Med Sci. 2016 Sep;352(3):231-8. doi: 10.1016/j.amjms.2016.05.012. Epub 2016 May 24.

• Responsible Party: Irene Sarosiek, Professor, Texas Tech University Health Sciences Center, El Paso
• ClinicalTrials.gov Identifier: NCT01469819
• Other Study ID Numbers: LUB-119
• First Posted: November 10, 2011
• Results First Posted: August 1, 2016
• Last Update Posted: June 9, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Irene Sarosiek, Texas Tech University Health Sciences Center, El Paso:

chronic constipation; constipation; idiopathic constipation; SmartPill; Wireless Motility Capsule; lubiprostone (Amitiza); small intestinal bacterial overgrowth

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive; Lubiprostone; Chloride Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action