Pentoxifylline plus mesalamine for adults with mild-to-moderate ulcerative colitis
Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis
This study will test whether adding pentoxifylline to standard mesalamine helps adults with mild to moderate ulcerative colitis have fewer symptoms and less inflammation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Al Fayyum) |
| Trial ID | NCT07349472 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial gives pentoxifylline alongside mesalamine to adults with mild-to-moderate ulcerative colitis and monitors clinical response and safety. Eligible participants are 18 or older, not pregnant, and not using systemic steroids, immunosuppressives, or biological therapies. Key exclusions include severe UC, diabetes, significant liver or kidney dysfunction, colorectal cancer, substance addiction, and known allergies to the study drugs. Outcomes will focus on symptom changes, tolerability, and adverse events during the treatment period.
Who should consider this trial
Good fit: Adults with mild-to-moderate ulcerative colitis who are not taking systemic steroids, immunosuppressives, or biologic therapies and who can comply with pregnancy-prevention requirements are appropriate candidates.
Not a fit: Patients with severe ulcerative colitis, those on biologics or immunosuppressives, people with uncontrolled diabetes or significant liver/kidney disease, pregnant or breastfeeding women, and those allergic to the study drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, adding pentoxifylline could reduce colon inflammation and improve symptoms for people with mild-to-moderate UC, offering a low-cost oral treatment option.
How similar studies have performed: Pentoxifylline has shown anti-inflammatory effects in small studies of other inflammatory conditions and limited IBD data, but robust evidence of benefit in ulcerative colitis is not yet established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Al Fayyum
- Fayoum University — Al Fayyum, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.