Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS) (IBS-PTX)
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
Irritable Bowel Syndrome
Drug: pentoxifylline placebo
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome|
- Severity of abdominal pain [ Time Frame: 3 months from the first day of treatment ] [ Designated as safety issue: No ]
Average daily severity of abdominal pain on a 0-10 scale [ Time Frame: Week 0 to week 12 ] [ Designated as safety issue: No ] Days with urgency [ Time Frame: Week 0 to week 12 ] [ Designated as safety issue: No ] Mean stool consistency using Bristol Stool Form Score [ Time Frame: Week 0 to week 12 ] [ Designated as safety issue: No ] Global satisfaction with control of IBS symptoms as assessed from the answer to the question "Have you had satisfactory relief of your IBS symptoms this week? Yes / No. "
- Mucosal byopsies [ Time Frame: 3 months from the first day of treatment ] [ Designated as safety issue: Yes ]
Effect of pentoxifylline treatment from mucosal byopsies on:
- epithelial morphology;
- mucosal immune cell subsets;
- changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: pentoxifylline||
Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.
Other Name: A
|Placebo Comparator: pentoxifylline placebo||
Drug: pentoxifylline placebo
Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.
Other Name: B
Disruption of the intestinal epithelial barrier is part of the pathophysiology of IBS favoring immune activation present in the mucosa of these patients and the development of symptoms in IBS. To evaluate the effect of treatment with pentoxifylline (PTX) in patients with IBS related to clinical response and modulation of the components of the epithelial barrier at the level of intestinal mucosa.
|Contact: LAURA RAMOS, MD||+34 firstname.lastname@example.org|
|Contact: ANA ALDEA, MDemail@example.com|
|Complejo Hospitalario Universitario de Canarias||Not yet recruiting|
|La Laguna, S/c Tenerife, Spain, 38320|
|Contact: LAURA RAMOS, MD +34 922675557 firstname.lastname@example.org|
|Contact: ANA ALDEA, MD +34922678115 email@example.com|
|Principal Investigator: LAURA RAMOS, MD|
|Principal Investigator:||LAURA RAMOS, MD||COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS|