Back to resultsEffect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS) (IBS-PTX)
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
pentoxifylline
pentoxifylline placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring pentoxifylline, tight junction signalling, intestinal epithelial barrier, irritable bowel syndrome
Eligibility 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
Sites / Locations
- Complejo Hospitalario Universitario de Canarias
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
pentoxifylline
pentoxifylline placebo
Arm Description
Outcomes
Primary Outcome Measures
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. "
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01542268
First Posted
September 23, 2011
Last Updated
March 5, 2012
Sponsor
Hospital Universitario de Canarias
1. Study Identification
Unique Protocol Identification Number
NCT01542268
Brief Title
Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)
Acronym
IBS-PTX
Official Title
Effect of Pentoxifylline on Tight Junctions of Intestinal Mucosa in Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario de Canarias
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
pentoxifylline, tight junction signalling, intestinal epithelial barrier, irritable bowel syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pentoxifylline
Arm Type
Active Comparator
Arm Title
pentoxifylline placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pentoxifylline
Other Intervention Name(s)
A
Intervention Description
Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.
Intervention Type
Drug
Intervention Name(s)
pentoxifylline placebo
Other Intervention Name(s)
B
Intervention Description
Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.
Primary Outcome Measure Information:
Title
Severity of abdominal pain
Description
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. "
Time Frame
3 months from the first day of treatment
Secondary Outcome Measure Information:
Title
Mucosal byopsies
Description
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)
Time Frame
3 months from the first day of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LAURA RAMOS, MD
Phone
+34 922675557
Email
laura7ramos@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ANA ALDEA, MD
Phone
+34922678115
Email
a.aldea@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LAURA RAMOS, MD
Organizational Affiliation
COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Canarias
City
La Laguna
State/Province
S/c Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAURA RAMOS, MD
Phone
+34 922675557
Email
laura7ramos@gmial.com
First Name & Middle Initial & Last Name & Degree
ANA ALDEA, MD
Phone
+34922678115
Email
a.aldea@gmail.com
First Name & Middle Initial & Last Name & Degree
LAURA RAMOS, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Pentoxifylline on Tight Junctions (TJs) of Intestinal Mucosa in Patients With Irritable Bowel Syndrome(IBS)
We'll reach out to this number within 24 hrs