Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Functional Dyspepsia; Constipation-predominant Irritable Bowel Syndrome

Treatments: Drug: Omeprazol; Drug: Linaclotide; Drug: Itopride; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05134584

RenJiH211012

Details and patient eligibility

About

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).

Full description

After being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20mL, once daily). Treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Outpatients
2. Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome Ⅲ criteria)
3. Diagnosis of IBS-C (Rome Ⅲ criteria)

Exclusion criteria

1. Helicobacter Pylori infection
2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
3. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

linaclotide

Experimental group

Description:

Patients in linaclotide group were given with oral, once daily 290 μg linaclotide for consecutively 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.

Treatment:

Drug: Itopride

Drug: Linaclotide

Drug: Omeprazol

lactulose

Active Comparator group

Description:

Patients in Lactulose group were given with oral, once daily 20 mL Lactulose for 4 weeks, along with once daily 20 mg omeprazole, three times daily 50 mg Itopride, for the first ten days of the treatment.

Treatment:

Drug: Itopride

Drug: Lactulose

Drug: Omeprazol