Efficacy of Rifaximin in Ulcerative Colitis Patient with Mild to Moderate Flare Up: A Randomized Controlled Trial

Abstract

Background: Gut microbiota is now being considered an important factor in promoting and maintaining inflammation in inflammatory bowel disease as well as in ulcerative colitis. Enteric infection is a common cause of microbial dysbiosis and is frequently found in ulcerative colitis patients. Traditional antibiotics use may induce untoward effect during long term use. Rifaximin, a rifampicin derivative is virtually unabsorbed after oral administration and does not cause serious systemic side effects. The potential therapeutic activity of Rifaximin in ulcerative colitis patients during mild to moderate flare up is not determined clearly still now. 

Objectives: To assess efficacy of Rifaximin in ulcerative colitis patients with mild to moderate flare up. 

Materials & Methods: This open label randomized controlled trial was conducted among 100 ulcerative colitis patients with mild to moder- ate disease. Intervention group received Rifaximin 550 mg twice daily along with 2.4 gm/d Mesalamine for 28 days. Control group received maximum dose of mesalamine 4.8 gm/ day for 28 days. All the patients were assessed by Partial Mayo Score along with CBC with ESR, CRP, Stool R/E, C/S, S. Albumin, Fecal Calprotectin at baseline and after 28 days. 

Results: In patients with mild discase activity 56.9% of patients were in Rifaximin group and 43.1% were in Mesalamine group. In patients with moderate disease activity 53.1% were in Rifaximin with Mesalamine group and 46.1% were in Masalamine group. After 28 days of intervention in Rifaximin with Mesalamine group 54.5% patients achieve remission with a statistically significant difference over Mesala- mine group (33.1%), 43.6% patients had mild disease activity, 1.8% patients had moderate disease activity, none of the patients had severe disease whether 20% patient from Mesalamine group developed severe disease after intervention. Side effects including hair fall and consti- pation were more in control group. 

Conclusion: Patient response to Rifaximin in ulcerative colitis with mild to moderate flare up appears to be favorable in this randomized controlled trial. To establish its efficacy longer follow up is warranted.