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

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

Detailed Description
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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.

Official Title
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Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: pentoxifylline
* Drug: pentoxifylline placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pentoxifylline<br> | Drug: pentoxifylline<br>* Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.<br>* Other names: A;|
| Placebo Comparator: pentoxifylline placebo<br> | Drug: pentoxifylline placebo<br>* Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.  | 3 months from the first day of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal byopsies | 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) | 3 months from the first day of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pentoxifylline, tight junction signalling, intestinal epithelial barrier, irritable bowel syndrome