Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4 Unknown 78 enrolled RenJi Hospital

RandomizedParallel-groupSingle-blindTreatment

Summary

This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).

Timeline

Start: 2021-01-01
Primary completion: 2021-12
Completion: 2022-02

Publications

Cheng L, Wang Q, Wu B, Yan X, Xu P, Qiu H, Chen S. Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial. J Gastroenterol Hepatol. 2025 May;40(5):1119-1127. doi: 10.1111/jgh.16925. Epub 2025 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lactulose	Other / unclassified	20 ml	Oral
Subject	Linaclotide	Peptide	290 ug	Oral
Background	Itopride	Small molecule	50 mg	—
Background	Omeprazol	Unknown	20 mg	—

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Summary

Timeline

Publications

Drugs

Indications