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

Irritable Bowel Syndrome Clinical Trial

— IBS-PTX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01542268
• Other study ID #: IBS-PTX
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 23, 2011
• Last updated: March 5, 2012
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Hospital Universitario de Canarias
• Contact: LAURA RAMOS, MD
• Phone: +34 922675557
• Email: laura7ramos[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Canarias	La Laguna	S/c Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario de Canarias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes