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NCT Number: NCT07349472

Pentoxifylline in Patients With Ulcerative Colitis

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in partial Mayo score

    Time frame: 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 outcomes

  1. Change in inflammatory bowel disease questionnaire-32 (IBDQ-32)

    Time frame: 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

  2. Change in level of fecal calprotectin

    Time frame: 6 months

    Fecal calprotectin is a non-invasive marker used as a prognostic tool in colitis

Sponsors and collaborators

Lead sponsor

Ihab Elsayed Hassan

Other

Registry information

Official study title

Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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