Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Mostafa Bahaa

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Nifuroxazide; Drug: Mesalamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05988528

8/2023

Details and patient eligibility

About

Ulcerative colitis (UC) is one of the most common types of chronic and non-specific inflammatory bowel diseases (IBD). It is characterized by cytokine-induced continuous and diffuse inflammatory infiltrations into the rectum's mucosa and extends proximally to the colon. Patients with UC predominantly have bloody diarrhea, abdominal pain, fecal urgency, and tenesmus, which extremely alters their quality of life.

Although the precise pathological mechanism of UC remains unclear, several studies have been outlined many factors that could involve in the pathogenesis of UC, including, but not limited to, initiation of the inflammatory response, disruption of oxidant/antioxidant status, dysregulation of the immune response, alteration of gut microbiota, and delaying epithelial barrier healing. Loss of intestinal barrier function and dysregulated immune response are the key events during colitis development

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Both male and female will be
• Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion criteria

• Breast feeding
• Significant liver and kidney function abnormalities
• Colorectal cancer patients
• Other inflammatory bowel diseases (CD).
• 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 Fenofibrate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

control group

Active Comparator group

Description:

Control group (Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months

Treatment:

Drug: Mesalamine

Nifuroxazide group

Active Comparator group

Description:

Patients will receive 1 g mesalamine three times daily plus Nifuroxazide 200 mg two times daily for 6 months

Treatment:

Drug: Nifuroxazide

Drug: Mesalamine