Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Our 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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Lactulose; Linaclotide

Criteria

Inclusion Criteria:

Outpatients aging between 18 and 75 years old and fulfilling Rome Ⅲ diagnostic criteria for FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) and IBS-C.

Exclusion Criteria:

(i) Other GI comorbidities, including inflammatory bowel disease, Helicobacter Pylori infection, diverticulitis, celiac disease, etc.; (ii) GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents; (iii) Complicated with severe cardiovascular and pulmonary diseases, malignancy, diabetes mellitus, chronic kidney disease, etc.