Evaluation of Clensia(®), a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG

Background: Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4 L (PEG 4 L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. Aim: To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4 L. Methods: In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2 L or PEG 4 L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. Results: 422 patients received Clensia (n = 213) or PEG 4 L (n = 209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4 L group respectively. Clensia was demonstrated to be equivalent to PEG 4 L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4 L 63%, P = 0.0314) and willingness-to-repeat (93.9% vs 82.2%, P = 0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4 L, P = 0.9388). Conclusions: The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4 L, with better gastrointestinal tolerability and acceptability.