Inflammatory Bowel Diseases
Conditions
Brief summary
The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.
Interventions
Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics. PTX exerts anti-inflammatory effects by inhibiting phosphodiesterase and activating the adenosine 2 receptor
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double-blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception
Exclusion criteria
\- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in health related quality of life | 6 months | Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the level of measured biomarkers. | 6 months | changes in the level of measured biomarkers through assessment serum level of TNF- alpha, serum IL-10, and gene expression of zonula occuldin-1(ZO-1). |
Countries
Egypt
Outcome results
None listed