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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
290μg once daily, 4 weeks
20mL once daily, 4 weeks
20mg twice daily for the first 10 days
RenJiH
Shanghai, Shanghai Municipality, China
RECRUITINGTreatment 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.
Time frame: Week 4
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline and Week 4
Changes in lower abdominal discomfort
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50mg three times daily for the first 10 days
Lower abdominal discomfort will be assessed using six-point scale (score 0 = not at all, 5 = extremely severe). Change = (Week 4 Score - Baseline Score).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Week 4