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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks.
24 mcg twice a day (BID) for 2 weeks.
Other Name: Amitiza
- 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.
- 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 ]
- 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.
- 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. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469819
|United States, Texas|
|Texas Tech University Health Sciences Center|
|El Paso, Texas, United States, 79905|
|Principal Investigator:||Irene Sarosiek, MD||Texas Tech University Health Sciences Center|