Pentoxifylline in Patients With Ulcerative Colitis

NCT ID: NCT07349472

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2027-02-20

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Group 1 (Placebo Group): Participants in this arm were administered an inert placebo capsule twice per day, in combination with mesalamine at a total daily dose of 3 g, given as 1 g three times daily

Group Type: ACTIVE_COMPARATOR

Mesalamine

Intervention Type: DRUG

Mesalamine is the standard first line treatment of ulcerative colitis

Pentoxifylline group

Group 2 (PTX Group): Individuals assigned to this group received PTX at a dose of 400 mg twice daily, together with mesalamine 1 g taken three times daily.

Group Type: ACTIVE_COMPARATOR

Mesalamine

Intervention Type: DRUG

Mesalamine is the standard first line treatment of ulcerative colitis

Pentoxifylline

Intervention Type: DRUG

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

Interventions

Mesalamine

Mesalamine is the standard first line treatment of ulcerative colitis

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ihab Elsayed Hassan

OTHER

Sponsor Role: lead

Responsible Party

Ihab Elsayed Hassan

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fayoum University

Al Fayyum, , Egypt

Countries

Egypt

Facility Contacts

Ehab Hassan, PhD

Role: primary

Ehassan@horus.edu.eg

Other Identifiers

87459

Identifier Type: -

Identifier Source: org_study_id