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The purpose of this study is to determine the therapeutics effectiveness of oral pentoxifylline treatment in patients with IBS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pentoxifylline | Active Comparator |
| |
| pentoxifylline placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pentoxifylline | Drug | Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal byopsies | Effect of pentoxifylline treatment from mucosal byopsies on:
| 3 months from the first day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LAURA RAMOS, MD | Contact | +34 922675557 | laura7ramos@gmail.com | |
| ANA ALDEA, MD | Contact | +34922678115 | a.aldea@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| LAURA RAMOS, MD | COMPLEJO HOSPITALARIO UNIVERSITARIO DE CANARIAS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Canarias | San Cristóbal de La Laguna | S/c Tenerife | 38320 | Spain |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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|
| pentoxifylline placebo | Drug | Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months. |
|
|
| D004066 | Digestive System Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |