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Pentoxifylline in Patients With Ulcerative Colitis

ConditionInflammatory Bowel Diseases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIhab Elsayed Hassan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Both male and female will be included

Negative pregnancy test and effective contraception.

Mild and moderate UC patients

Disqualifiers

Breast feeding

Significant liver and kidney function abnormalities

Diabetic patients

Colorectal cancer patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Pentoxifylline groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

Change in level of fecal calprotectin

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ihab Elsayed Hassan

Lead sponsor

Tanta University

Sponsor institution

Source ClinicalTrials.gov
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