Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4

• Conditions: Constipation-predominant Irritable Bowel Syndrome; Functional Dyspepsia
• Interventions: Drug: Linaclotide; Drug: Lactulose; Drug: Omeprazol; Drug: Itopride

• Registration Number: NCT05134584
• Lead Sponsor: RenJi Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-14
• Study First Submitted QC: 2021-11-14
• Study First Posted: 2021-11-26
• Last Update Submitted: 2021-11-29
• Primary Completion: 2021-12
• Last Update Posted: 2021-12-13
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactulose	Omeprazol	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.
linaclotide	Linaclotide	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.
linaclotide	Omeprazol	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.
linaclotide	Itopride	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.
lactulose	Lactulose	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.
lactulose	Itopride	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.

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction assessed by the VAS	Week 4	Treatment satisfaction will be assessed by the Visual Analogue Scale: score 0=not at all, 1=partial relief of general GI symptoms, 2=complete relief of general GI symptoms.

Secondary Outcome Measures

Name	Time	Method
Changes in stool frequency	Baseline and Week 4	Stool frequency will be assessed using bowel movement (BM), spontaneous bowel movement (SBM), complete spontaneous bowel movement (CSBM) during the past 7 days.; Change = (Week 4 Score - Baseline Score).
Changes in stool consistency	Baseline and Week 4	Stool consistency will be assessed using Bristol Stool Form Scale (BSFS), which contains 7 types of stool consistency.; Change = (Week 4 Score - Baseline Score).
Changes in defecation time	Baseline and Week 4	Defecation time will be assessed using approximate duration: less than 15 minutes, 15-30 minutes, more than 30 minutes.
Changes in the depression status	Baseline and Week 4	The depression status will be assessed using the Patient Health Questionnaire (PHD-9).; Change = (Week 4 Score - Baseline Score).
Changes in defecation straining score	Baseline and Week 4	Defecation straining score will be assessed using six-point scale (score 0 = effortless, 5 = extremely laborious).; Change = (Week 4 Score - Baseline Score).
Changes in sensation of complete evacuation	Baseline and Week 4	Sensation of complete evacuation will be assessed using five-point scale (score 0 = not at all, 4 = complete totally).; Change = (Week 4 Score - Baseline Score).
Changes in lower abdominal discomfort	Baseline and Week 4	Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).; Change = (Week 4 Score - Baseline Score).
Changes in lower abdominal pain	Baseline and Week 4	Lower abdominal pain will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe).; Change = (Week 4 Score - Baseline Score).
Changes in FD symptoms	Baseline and Week 4	FD symptoms will be assessed using Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM).; Change = (Week 4 Score - Baseline Score).
Changes in the anxiety status	Baseline and Week 4	The anxiety status will be assessed using the Generalized Anxiety Disorder scale (GAD-7).; Change = (Week 4 Score - Baseline Score).

Trial Locations

Locations (1)

RenJiH; 🇨🇳 Shanghai, Shanghai, China