Pentoxifylline in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mesalamine, Pentoxifylline.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis
Overview
Ulcerative colitis (UC) is a persistent, idiopathic form of inflammatory bowel disease (IBD) marked by uninterrupted inflammation of the colon's mucosal lining, usually starting at the rectum and progressing proximally in a continuous manner. It manifests clinically with recurrent episodes of abdominal pain, bloody diarrhea, urgency, tenesmus, and weight loss. The precise cause of UC is still unknown; however, it is thought to arise from a multifactorial interaction involving genetic susceptibility, immune system dysregulation, disturbances in gut microbiota composition, and various environmental factors.
Interventions
- Drug Mesalamine
Mesalamine is the standard first line treatment of ulcerative colitis - Drug Pentoxifylline
Pentoxifylline (PTX), a methylxanthine derivative and non-selective phosphodiesterase inhibitor, has been extensively studied for its anti-inflammatory and immunomodulatory actions. It inhibits TNF-α production at the transcriptional level and downregulates several inflammatory cytokines, including IL-1β, IL-6, and interferon-γ
Primary outcome measures
- Change in partial Mayo score [Time frame: 6 months]
Secondary outcome measures (2)
- Change in inflammatory bowel disease questionnaire-32 (IBDQ-32) [Time frame: 6 months]
- Change in level of fecal calprotectin [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Both male and female will be included
- Negative pregnancy test and effective contraception.
- Mild and moderate UC patients
Exclusion criteria
- Breast feeding
- Significant liver and kidney function abnormalities
- Diabetic patients
- Colorectal cancer patients
- Patients with severe UC
- Patients taking rectal or systemic steroids
- Patients taking immunosuppressives or biological therapies
- Addiction to alcohol and / or drugs
- Known allergy to the studied medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Fayoum University — Al Fayyum
Identifiers
NCT: NCT07349472 · 87459