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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988528
• Other study ID #: 8/2023
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: August 20, 2023
• Est. completion date: November 20, 2028

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: Mostafa Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 20, 2028
• Est. primary completion date: August 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

Drug:
• Mesalamine
Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis.
• Nifuroxazide
Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Bahaa

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the improvement in health-related quality of life	The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224	6 months