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

H

Hospital Universitario de Canarias

Status and phase

Unknown
Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Drug: pentoxifylline placebo
Drug: pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT01542268
IBS-PTX

Details and patient eligibility

About

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

Full 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.

Enrollment

59 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

59 participants in 2 patient groups, including a placebo group

pentoxifylline
Active Comparator group
Treatment:
Drug: pentoxifylline
pentoxifylline placebo
Placebo Comparator group
Treatment:
Drug: pentoxifylline placebo

Trial contacts and locations

1

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Central trial contact

LAURA RAMOS, MD; ANA ALDEA, MD

Data sourced from clinicaltrials.gov

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