Pentoxifylline in Patients With Ulcerative Colitis

Ihab Elsayed Hassan

Status and phase: Not yet enrolling; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Mesalamine; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT07349472

87459

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Mesalamine

Pentoxifylline group

Active Comparator group

Description:

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.

Treatment:

Drug: Pentoxifylline

Drug: Mesalamine