Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)

Phase 4

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: pentoxifylline placebo; Drug: pentoxifylline

• Registration Number: NCT01542268
• Lead Sponsor: Hospital Universitario de Canarias

Brief Summary

The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2012-02-24
• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Posted: 2012-03-02
• Last Update Submitted: 2012-03-05
• Last Update Posted: 2012-03-06
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Age between 18 and 65 years old
• Most of the patient with IBS will be chose between the patients who go to Digestive System ambulatory external medical office from our Center.
• Be studied and with clinical monitoring al least 6 months before be included.
• Fulfill with Roma III Criteria for IBS (Gastroenterology 2006;130:1377-90) with moderate-severe seriousness according to Modification Francis Scale

Exclusion Criteria

• 2 weeks before colon biopsia, any patient cann´t take salicylates, NSAID, antibiotics,anticholinergics,opiates or any other medication / product for asintomatic treatment of diarrea.
• 3 months before colon biopsia, any patient cann´t take medicaments as corticoides, antihistamines or immunosuppressive
• 6 months before colon biopsia, any patient cann´t recive radiotherapy or chemotherapy.
• Pentoxifilina Alergic Reactions
• Pregnants
• Grave kidney failure
• Grave Hepatic failure
• Menthal or legal disability to sign the consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pentoxifylline placebo	pentoxifylline placebo	-
pentoxifylline	pentoxifylline	-

Primary Outcome Measures

Name	Time	Method
Severity of abdominal pain	3 months from the first day of treatment	Clinical endpoint: 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. "

Secondary Outcome Measures

Name	Time	Method
Mucosal byopsies	3 months from the first day of treatment	Effect of pentoxifylline treatment from mucosal byopsies on: 1. epithelial morphology; 2. mucosal immune cell subsets; 3. changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)

Trial Locations

Locations (1)

Complejo Hospitalario Universitario de Canarias; 🇪🇸 La Laguna, S/c Tenerife, Spain