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Adding linaclotide to PEG did not improve bowel prep quality in high-risk colonoscopy patients undergoing screening procedures

Adding linaclotide to PEG did not improve bowel prep quality in high-risk colonoscopy patients…
Photo by CDC / Unsplash
Key Takeaway
Linaclotide plus PEG did not improve prep quality but increased right-sided polyp counts compared to placebo plus PEG in this trial.

This multicenter, randomized, double-blind trial evaluated the efficacy of adding linaclotide to polyethylene glycol for bowel preparation in patients at increased risk of inadequate cleansing. The study included 672 patients in the modified intention-to-treat analysis and 574 in the per-protocol analysis. Participants received either a two-day regimen of linaclotide with polyethylene glycol or placebo with polyethylene glycol before their colonoscopy procedures.

results showed no statistically significant difference between the two groups regarding the rate of adequate bowel preparation. The odds ratios favored the linaclotide group but confidence intervals crossed unity, indicating non-significance. Similarly, the mean number of adenomas detected per colonoscopy did not differ significantly between the treatment and control arms across both analysis populations.

Despite the lack of improvement in primary outcomes, the study observed a significant increase in the mean number of polyps found in the right colon among patients receiving linaclotide and polyethylene glycol. This finding was consistent across the overall population and specifically noted in patients aged 70 years and older. Safety data were not reported in the provided abstract, though the study design suggests a focus on tolerability.

Study Details

Study typeRct
Sample sizen = 672
EvidenceLevel 2
Follow-up840.0 mo
PublishedJun 2026
View Original Abstract ↓
BACKGROUND AND AIM: The benefit of combining linaclotide with polyethylene glycol (PEG) for improving bowel preparation quality and adenoma detection in patients at risk for inadequate bowel preparation remains uncertain. This study aimed to evaluate its efficacy and safety. METHODS: From August 2022 to July 2023, a multicenter, randomized trial assigned participants to a 2-day linaclotide or placebo plus PEG regimen. The primary endpoints included adequate bowel preparation rate and mean number of adenomas detected per colonoscopy. RESULTS: The modified intention-to-treat (mITT) (n=672) and per-protocol (n=574) analyses showed no significant differences in adequate bowel preparation rates (mITT: OR 1.26, 95% CI 0.73-2.16, P=0.406; per-protocol: OR 1.46, 95% CI 0.80-2.66, P=0.222) or the mean number of adenomas (mITT: mean difference -0.02, 95% CI -0.19-0.15, P=0.832; per-protocol: mean difference -0.06, 95% CI -0.25-0.13, P=0.530) between groups. However, linaclotide and PEG increased the mean number of polyps in the right colon (0.54 ± 1.9 vs. 0.27 ± 0.8; mean difference -0.27, 95% CI -0.49- -0.05, P=0.016), particularly in patients aged ≥70 years (mean difference -1.30, 95% CI -2.48- -0.13, P=0.033). CONCLUSIONS: A 2-day linaclotide regimen failed to improve the primary endpoints of bowel preparation adequacy or adenoma detection in high-risk patients.
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