Application of oral sulfate solution combined with linaclotide in bowel preparation for colonoscopy

TL;DR

This study compared the effectiveness of adding linaclotide to oral sulfate solution for colonoscopy prep, finding no improvement in cleansing but a possible reduction in bloating.

Contribution

The study is the first to rigorously compare linaclotide combined with oral sulfate solution to standard bowel prep methods in a randomized trial.

Findings

Adding linaclotide to OSS did not significantly improve bowel preparation rates compared to OSS alone.

Both OSS groups had significantly better bowel preparation than the PEG group.

The OSS + Linaclotide group reported less bloating than other groups.

Abstract

High-quality bowel preparation is essential for accurate colonoscopy. Currently, linaclotide is used as an adjunctive agent supporting bowel preparation, but evidence for its combination with oral sulfate solution (OSS) remains limited. This study aimed to evaluate whether the addition of linaclotide to OSS could improve the efficacy of bowel preparation.

This single-blind, randomized controlled trial enrolled outpatients scheduled for colonoscopy. Participants were randomly assigned (1:1:1) to one of three groups: the OSS + Linaclotide group, the OSS group, or the polyethylene glycol (PEG) group. The primary outcome was the adequate bowel preparation rate, while secondary outcomes included tolerability, colonoscopy findings, and safety. Efficacy endpoints were assessed in the modified intention-to-treat (mITT) population, and safety was evaluated in the as-treated population.

A total of 370 patients were included in the mITT analysis. There was no statistically significant difference in the adequate bowel preparation rate between the OSS + Linaclotide group and the OSS group (86.5% vs. 88.0%; unadjusted relative risk [RR], 0.98; 95% confidence interval [CI], 0.89–1.08; p = 0.723). In the unadjusted analysis, both the OSS + Linaclotide group (86.5% vs. 73.9%; unadjusted RR, 1.17; 95% CI, 1.03–1.33; p = 0.013) and the OSS group (88.0% vs. 73.9%; unadjusted RR, 1.19; 95% CI, 1.05–1.35; p = 0.005) demonstrated significantly higher adequate bowel preparation rates than the PEG group. Moreover, the analysis adjusted for covariates showed no statistically significant differences between groups (p > 0.05). In exploratory analysis, patient-reported incidence of bloating was less frequent in the OSS + Linaclotide group (4.0% vs. 16.0% vs. 11.8%, p = 0.007), with no increase in nausea, vomiting, or other adverse events. No significant between-group differences were observed in other tolerability measures or colonoscopy findings.

This study did not meet its primary endpoint. Linaclotide added to OSS provided no additional cleansing efficacy over OSS alone or PEG. Exploratory analysis found that the combination may reduce bloating, a potential tolerability advantage requiring further verification in future studies.

Linaclotide as an adjunct to oral sulfate solution for colonoscopy preparation.Infographic summarizes a clinical trial on bowel preparation methods for colonoscopy in 370 adults, median age forty-five. Three groups compared: OSS plus linaclotide, OSS alone, and PEG, all using standardized dosing schedules. Primary outcome is bowel cleansing efficacy measured by BBPS score. Findings show bowel preparation adequacy rates were eighty-six point five percent for OSS plus linaclotide, eighty-eight percent for OSS, and seventy-three point nine percent for PEG. Statistical results comparing relative risks are also displayed.

Linaclotide as an adjunct to oral sulfate solution for colonoscopy preparation.

Figures