Pentoxifylline in Patients With Ulcerative Colitis

Sponsor
Ihab Elsayed Hassan
Study ID
NCT07349472
Phase
PHASE2
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesalamine — DRUG
    Mesalamine is the standard first line treatment of ulcerative colitis
  • Pentoxifylline — 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

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Jan 20, 2026
Status verified
Apr 2026
Primary completion
Jan 20, 2027
Completion
Feb 20, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: 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.

Primary Outcome Measure

Change in partial Mayo score [ Time Frame: 6 months ]

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