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

This study is not yet open for participant recruitment.
Verified March 2012 by Hospital Universitario de Canarias
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01542268
First received: September 23, 2011
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: pentoxifylline
Drug: pentoxifylline placebo
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • Severity of abdominal pain [ Time Frame: 3 months from the first day of treatment ] [ Designated as safety issue: No ]

    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:
  • 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:

    1. epithelial morphology;
    2. mucosal immune cell subsets;
    3. changes of gene expression of genes related to intestinal epithelial barrier component( tight junctions)


Estimated Enrollment: 59
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)
Arms Assigned Interventions
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 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542268

Contacts
Contact: LAURA RAMOS, MD +34 922675557 laura7ramos@gmail.com
Contact: ANA ALDEA, MD +34922678115 a.aldea@gmail.com

Locations
Spain
Complejo Hospitalario Universitario de Canarias Not yet recruiting
La Laguna, S/c Tenerife, Spain, 38320
Contact: LAURA RAMOS, MD     +34 922675557     laura7ramos@gmial.com    
Contact: ANA ALDEA, MD     +34922678115     a.aldea@gmail.com    
Principal Investigator: LAURA RAMOS, MD            
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: LAURA RAMOS, MD COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS
  More Information

No publications provided

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01542268     History of Changes
Other Study ID Numbers: IBS-PTX
Study First Received: September 23, 2011
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital Universitario de Canarias:
pentoxifylline
tight junction signalling
intestinal epithelial barrier
irritable bowel syndrome

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on May 21, 2013