Background: To evaluate the effect of using linaclotide as an adjunctive agent with 3L polyethylene glycol (PEG) for bowel preparation among patients with Bristol stool form (BSFS) 1-2.
Methods: Patients with BSFS 1-2 randomly received either 3L PEG (group A) or linaclotide plus 3L PEG (group B), patients with BSFS 3-7 received 3L PEG (group C) for bowel preparation. The primary outcome was the rate of adequate bowel preparation. The secondary endpoints were the polyp detection rate (PDR), acceptability and tolerability.
Results: A total of 315 patients who underwent colonoscopy were enrolled. In per-protocol analysis, patient in group B attained significantly satisfactory bowel preparation rate than group A (77.9% vs 61.8%, PAB=0.049). The PDR in group B was significantly higher than group A (32.7% vs 15.7%, PAB=0.004), especially in rectosigmoid (25.0% vs 8.8%, PAB=0.002).
Conclusion: 3L PEG plus 290ug Linaclotide can significantly improve the quality of bowel preparation and the colorectal polyps detection rate in patients with BSFS 1-2. The bowel preparation regimens is an effective and well-tolerated bowel preparation regimen.
Trial registration: The study was registered at Chinese ClinicalTrials.gov (ChiCTR2100050437, 27/8/2021)