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

NCT05988528 | Completed Phase 2

• 1 other identifier: 8/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Drug: Mesalamine

Nifuroxazide group

ACTIVE COMPARATOR

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

Drug: Mesalamine; Drug: Nifuroxazide

Interventions

Mesalamine DRUG

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 group; control group

Nifuroxazide DRUG

Nifuroxazide is an oral antibiotic that has been approved as an effective antidiarrheal agent with no side effects in several gastrointestinal infections

Nifuroxazide group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (1)

• AlRasheed HA, Abdallah MS, El-Khateeb E, Kamal M, Alrubia S, Alsegiani AS, Ahmed TI, Bahaa MM. A Randomized Controlled Pilot Study Evaluating the Safety and Efficacy of Nifuroxazide in Patients with Ulcerative Colitis. Drug Des Devel Ther. 2025 Jun 30;19:5539-5552. doi: 10.2147/DDDT.S522755. eCollection 2025.

  PMID: 40620467 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Mesalamine; nifuroxazide

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 20, 2023
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

EG (1)