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Publications

Journal Article Randomized Controlled Trial Epublish

PubMed: 40620467 DOI: 10.2147/DDDT.S522755

A Randomized Controlled Pilot Study Evaluating the Safety and Efficacy of Nifuroxazide in Patients with Ulcerative Colitis.

Drug Des Devel Ther 19:5539-5552

Authors: Hayam Ali AlRasheed, Mahmoud S Abdallah, Eman El-Khateeb, Marwa Kamal, Sarah Alrubia, Amsha S Alsegiani, Tarek I Ahmed, Mostafa M Bahaa

Affiliations

  • Department of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.
  • Department of Clinical Pharmacy, Faculty of Pharmacy, University of Sadat City (USC), Sadat City, Menoufia, 32879, Egypt.
  • Department of PharmD, Faculty of Pharmacy, Jadara University, Irbid, 21110, Jordan.
  • Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
  • Certara Predictive Technologies (CPT), Simcyp Division, Sheffield, UK.
  • Clinical Pharmacy Department, Faculty of Pharmacy, Fayoum University, Fayoum, Egypt.
  • Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
  • Internal Medicine Department, Faculty of Medicine, Fayoum University, Fayoum, Egypt.
  • Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt.

Abstract

Background

The therapeutic potential of nifuroxazide in colitis has been explored in several experimental studies of ulcerative colitis (UC).

Aim

To evaluate the efficacy of nifuroxazide in patients with UC.

Methods

Fifty patients with mild to moderate UC were randomly assigned into two groups (n = 25 each). The placebo group received a placebo alongside mesalamine (1 g three times daily [t.i.d.]) for six months. The nifuroxazide group received nifuroxazide (200 mg twice daily) in combination with mesalamine (1 g t.i.d). A gastroenterologist assessed disease severity using the partial Mayo score (PMS). Serum levels of C-reactive protein (CRP), nuclear factor kappa B (NF-κB), interleukin-6 (IL-6), and signal transducer and activator of transcription 3 (STAT3) were measured before and after treatment. Quality of life was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ-32). Primary outcomes: Change in PMS. Secondary outcomes: change in IBDQ-32 and in the level of measured biomarkers.

Results

Baseline measurements were comparable between groups (p > 0.05). Post-treatment values showed significant improvements within both groups compared to baseline. However, the nifuroxazide group demonstrated significantly greater improvements than the placebo group, including reductions in PMS (p = 0.005) and increases in IBDQ scores (p = 0.002). Additionally, significant decreases were observed in IL-6 (p = 0.03), NF-κB (p = 0.03), CRP (p = 0.02), and STAT3 (p = 0.03) levels. The placebo group had a response rate of 56% (14/25) and a remission rate of 24% (6/25), whereas the nifuroxazide group achieved a response rate of 76% (19/25) and a remission rate of 56% (14/25), based on PMS.

Conclusion

Co-administration of nifuroxazide with mesalamine improved clinical outcomes, including higher response and remission rates, reduced inflammation by reducing IL-6/STAT3, and enhanced quality of life in patients with UC, compared to mesalamine alone.

Trial Registration Identifier

NCT05988528.

MeSH

Pilot Projects, Pilots, Colitis, Safety, Interleukin-6, Mesalamine, Drug Therapy, Therapeutics, Colitis, Ulcerative