Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome

Conditions
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Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Linaclotide
* Drug: Lactulose
* Drug: Omeprazol
* Drug: Itopride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Diagnosis of FD (including postprandial distress syndrome [PDS] with or without epigastric pain syndrome [EPS]) (Rome Ⅲ criteria) Diagnosis of IBS-C (Rome Ⅲ criteria) Exclusion Criteria: Helicobacter Pylori infection GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: linaclotide<br>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. | Drug: Linaclotide<br>* 290μg once daily, 4 weeks<br>* Other names: Linzess;Drug: Omeprazol<br>* 20mg twice daily for the first 10 days<br>Drug: Itopride<br>* 50mg three times daily for the first 10 days<br>|
| Active Comparator: lactulose<br>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. | Drug: Lactulose<br>* 20mL once daily, 4 weeks<br>* Other names: Duphalac;Drug: Omeprazol<br>* 20mg twice daily for the first 10 days<br>Drug: Itopride<br>* 50mg three times daily for the first 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction assessed by the VAS | 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. | Week 4 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose