Lubiprostone Effects on Visceral Pain Sensitivity

Status Completed

Clinical Trial Summary

The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.

Clinical Trial Description

Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01166789
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	Phase 1
Start date	February 2008
Completion date	August 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03720314` - Microbiota Profiling in IBS
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT05213910` - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains	N/A
Recruiting	`NCT05985018` - Traditional Dietary Advice Vs. Mediterranean Diet in IBS	N/A
Completed	`NCT04486469` - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.	N/A
Completed	`NCT06407609` - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS	N/A
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04145856` - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico	Phase 4
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT06369753` - Visible Abdominal Distension	N/A
Not yet recruiting	`NCT05157867` - In Vivo Effects of Amylase Trypsin Inhibitors	N/A
Not yet recruiting	`NCT05100719` - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)	N/A
Recruiting	`NCT05001997` - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome	N/A
Recruiting	`NCT02953171` - Probiotics in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT03266068` - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed	`NCT02977975` - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT03318614` - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster	Phase 2/Phase 3
Completed	`NCT02980406` - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level	N/A