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

Hospital Universitario de Canarias59 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

pentoxifyllineDRUG

Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.

pentoxifylline placeboDRUG

Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Complejo Hospitalario Universitario de Canarias

San Cristóbal de La Laguna, S/c Tenerife, Spain

Outcomes

Primary Outcomes

Severity of abdominal pain

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. "

Time frame: 3 months from the first day of treatment

Secondary Outcomes

Mucosal byopsies

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)

Time frame: 3 months from the first day of treatment

Central Contacts

LAURA RAMOS, MD

CONTACT

+34 922675557 laura7ramos@gmail.com

ANA ALDEA, MD

CONTACT

+34922678115 a.aldea@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.