Pentoxifylline in Patients With Ulcerative Colitis

Clinical Study Evaluating Safety and Efficacy of 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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Mesalamine; Drug: Pentoxifylline

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Al Fayyum, Egypt, 54687
    • Recruiting
    • Fayoum University
    • Contact: Ehab Hassan, PhD; Phone Number: 01067831661; Email: Ehassan@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Mesalamine; Mesalamine is the standard first line treatment of ulcerative colitis
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.	Drug: Mesalamine; Mesalamine is the standard first line treatment of ulcerative colitis; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in partial Mayo score	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory bowel disease questionnaire-32 (IBDQ-32)	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	6 months
Change in level of fecal calprotectin	Fecal calprotectin is a non-invasive marker used as a prognostic tool in colitis	6 months

Collaborators and Investigators

• Sponsor: Ihab Elsayed Hassan

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Purinones; Purines; Phenols; Benzene Derivatives; Acids, Carbocyclic; Aminobenzoates; Benzoates; Salicylates; Hydroxybenzoates; Xanthines; Theobromine; meta-Aminobenzoates; Aminosalicylic Acids; Pentoxifylline; Mesalamine
• Other Study ID Numbers: 87459

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No