NCT07349472

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
9mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

January 9, 2026

Last Update Submit

April 11, 2026

Conditions

Inflammatory Bowel Diseases

Outcome Measures

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

    6 months

Secondary Outcomes (2)

  • Change in inflammatory bowel disease questionnaire-32 (IBDQ-32)

    6 months

  • Change in level of fecal calprotectin

    6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Pentoxifylline group

ACTIVE COMPARATOR

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: MesalamineDrug: Pentoxifylline

Interventions

MesalamineDRUG

Mesalamine is the standard first line treatment of ulcerative colitis

Control groupPentoxifylline group
PentoxifyllineDRUG

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

Pentoxifylline group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Both male and female will be included
  • Negative pregnancy test and effective contraception.
  • Mild and moderate UC patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, 54687, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

MesalaminePentoxifylline

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsTheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

January 20, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

EG(1)