AT A GLANCE

A new study published in Drug Design, Development, and Therapy reports that co-administration of nifuroxazide with mesalamine leads to better clinical outcomes versus mesalamine alone in ulcerative colitis (UC).¹

“The therapeutic potential of nifuroxazide in colitis has been explored in several experimental studies of UC,” explain study authors AlRasheed et al. “Till now, there is no clinical study that investigated the effect of nifuroxazide in patients with UC.”

For study purposes, the authors enrolled 50 patients with mild to moderate UC and randomly assigned them to receive either placebo alongside mesalamine (1 g three times daily) for six months or nifuroxazide (200 mg twice daily) in combination with mesalamine (1 g three times daily). 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, and a gastroenterologist assessed disease severity in all participants using the partial Mayo score (PMS), while quality of life was evaluated using the Inflammatory Bowel Disease Questionnaire (IBDQ-32). The primary study outcome of interest included the change in PMS, while secondary outcomes included changes in the IBDQ-32 score and levels of measured biomarkers.

According to the authors, baseline measurements were comparable between the study groups, and both groups experienced significant improvements in post-treatment values compared to baseline. However, the nifuroxazide group demonstrated significantly greater improvements than the placebo group, including reductions in PMS and increases in IBDQ scores. Significant reductions were also observed in IL-6, NF-κB, CRP, and STAT3 levels. Based on the PMS, the response rates were 56% (14/25) and 76% (19/25) in the placebo and nifuroxazide groups, while remission rates were 24% (6/25) and 56% (14/25).

“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,” conclude the authors.

Reference

1.     AlRasheed HA, Abdallah MS, El-Khateeb E, et al. A randomized controlled pilot study evaluating the safety and efficacy of nifuroxazide in patients with ulcerative colitis. Drug Des Devel Ther. 2025;19:5539–5552.