Efficacy, safety and tolerability of oral sulfate tablet for bowel preparation in patients with inflammatory bowel disease: Multicenter randomized controlled study

Abstract

Background and Aims: We evaluated the efficacy, safety and tolerability of novel oral sulphate tablets [OSTs] vs 2 L of polyethylene glycol and ascorbate [PEG/Asc] in patients with inflammatory bowel disease [IBD].

Patients and Methods: A total of 110 patients with clinically inactive IBD were enrolled in this single-blind multicentre non-inferiority study. Patients were randomly assigned to the OST or 2 L PEG/Asc group and we applied a split-dose regimen. The primary efficacy endpoint was bowel cleansing success rate defined as Harefield Cleansing Scale Grade A or B. The secondary endpoints were perfect preparation rate, the presence of air bubbles, safety as assessed by laboratory abnormalities and self-reported adverse events, or IBD symptom flare-ups. Tolerability was assessed by a pre-procedural visual analog scale [VAS] interview.

Results: Both groups showed high cleansing success rates [98.1%] and there was no significant difference in perfect preparation rate. The proportion of a bubble score 0 was significantly higher in the OST group [94.5% vs 50.0%, p < 0.001]. There was no significant intergroup difference in vomiting or bloating. Symptom flare-ups occurred in two OST group patients. No clinically significant blood test abnormalities were noted in either group. Ease of ingestion and taste scores were significantly higher in the OST group. More patients in the OST group [94.5%] wanted to take the same preparation agent for their next colonoscopy.

Conclusions: Both OST and 2 L PEG/Asc demonstrated high successful cleansing and safety in patients with inactive IBD. OST achieved higher satisfaction than 2 L PEG/Asc. Our results suggest that the OST split-dose regimen is effective and safe for patients with inactive IBD.