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

Primary Purpose

Chronic Idiopathic Constipation

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lubiprostone

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation focused on measuring chronic constipation, constipation, idiopathic constipation, SmartPill, Wireless Motility Capsule, lubiprostone (Amitiza), small intestinal bacterial overgrowth

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Texas Tech University Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lubiprostone

Arm Description

Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.

Outcomes

Primary Outcome Measures

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.

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

Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).

Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.

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.

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.

Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.

Full Information

NCT ID

NCT01469819

First Posted

October 28, 2011

Last Updated

May 5, 2017

Sponsor

Texas Tech University Health Sciences Center, El Paso

Collaborators

Takeda Pharmaceuticals North America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01469819

Brief Title

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

Official Title

The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas Tech University Health Sciences Center, El Paso

Collaborators

Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Idiopathic Constipation

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lubiprostone

Arm Type

Experimental

Arm Description

Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Lubiprostone

Other Intervention Name(s)

Amitiza

Intervention Description

24 mcg twice a day (BID) for 2 weeks.

Primary Outcome Measure Information:

Title

Description

Time Frame

Measured at baseline and 2 weeks after baseline.

Secondary Outcome Measure Information:

Title

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

Title

Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.

Description

Time Frame

Measured at baseline and 2 weeks after baseline.

Title

Time Frame

Measured at baseline and 2 weeks after baseline.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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: At least 25% of stools are very hard and/or hard stools Sensation of incomplete evacuation following at least 25% of bowel movements. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irene Sarosiek, MD

Organizational Affiliation

Texas Tech University Health Sciences Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Tech University Health Sciences Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27650225

Citation

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.

Results Reference

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

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