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

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

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

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: pentoxifylline; Drug: pentoxifylline placebo

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 Type: Interventional
• Enrollment (Anticipated): 59
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: LAURA RAMOS, MD; Phone Number: +34 922675557; Email: laura7ramos@gmail.com
• Study Contact Backup: Name: ANA ALDEA, MD; Phone Number: +34922678115; Email: a.aldea@gmail.com

Study Locations

• Spain
  • S/c Tenerife
    • La Laguna, S/c Tenerife, Spain, 38320
      • Complejo hospitalario Universitario de Canarias
      • Contact: ANA ALDEA, MD; Phone Number: +34922678115; Email: a.aldea@gmail.com
      • Contact: LAURA RAMOS, MD; Phone Number: +34 922675557; Email: laura7ramos@gmial.com
      • Principal Investigator: Laura Ramos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: pentoxifylline	Drug: pentoxifylline; Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.; Other Names: 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 Names: B

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario de Canarias
• Investigators: Principal Investigator: LAURA RAMOS, MD, Complejo hospitalario Universitario de Canarias

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): January 1, 2013
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 6, 2012
• Last Update Submitted That Met QC Criteria: March 5, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: pentoxifylline; irritable bowel syndrome; tight junction signalling; intestinal epithelial barrier
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: IBS-PTX