Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial.

Abstract

Background and aim: Linaclotide is effective in relieving constipation-predominant irritable bowel syndrome symptoms. However, few studies focus on the efficacy of linaclotide for overlapping symptoms of functional dyspepsia among irritable bowel syndrome patients. This study aimed to assess the efficacy of linaclotide compared with lactulose in patients with functional dyspepsia and constipation-predominant irritable bowel syndrome overlap.

Methods: Seventy-eight patient were randomized (2:1) to receive linaclotide 290 μg or lactulose 20 mL daily for 4 weeks. The primary endpoint was the overall treatment satisfaction for gastrointestinal symptom relief. The secondary endpoints included score changes in functional dyspepsia, constipation-predominant irritable bowel syndrome symptoms, and psychological status.

Results: Seventy-one patients (47 with linaclotide and 24 with lactulose) completed the study. A higher proportion of patients receiving linaclotide reported partial or complete relief of gastrointestinal symptoms compared with patients receiving lactulose (87.2% vs. 54.2%, p = 0.002). Dyspeptic symptoms (postprandial fullness/early satiety and bloating) and bowel symptoms (stool frequency, consistency, straining, sensation of complete evacuation, and lower abdominal discomfort) showed greater improvement in linaclotide-treated patients than in lactulose group (p < 0.05).

Conclusions: Linaclotide shows better efficacy for functional dyspepsia and constipation-predominant irritable bowel syndrome overlap compared with lactulose.

Trial registration: ClinicalTrials.gov: NCT05134584.