Inflammatory Bowel Diseases
Conditions
Brief summary
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
DRUGMesalamine
Mesalamine is the standard first line treatment of ulcerative colitis
DRUGPentoxifylline
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
Sponsors
Ihab Elsayed Hassan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in partial Mayo score | 6 months | The Partial Mayo Score (PMS) was utilized to evaluate disease activity in patients with UC. This non-invasive index comprises three components: stool frequency, rectal bleeding, and the physician's global assessment, yielding a total score between 0 and 9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory bowel disease questionnaire-32 (IBDQ-32) | 6 months | The IBDQ-32 is the most widely used tool for evaluating disease-specific quality of life in randomized clinical trials involving UC. It measures four domains: emotional function, social function, bowel symptoms, and systemic symptoms |
| Change in level of fecal calprotectin | 6 months | Fecal calprotectin is a non-invasive marker used as a prognostic tool in colitis |
Countries
Egypt
Outcome results
None listed