Functional Dyspepsia, Constipation-predominant Irritable Bowel Syndrome
Conditions
Keywords
functional dyspepsia, irritable bowel syndrome, constipation, linaclotide, lactulose
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.
Interventions
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and investigators were not masked to group assignment. An independent statistician was masked for the data analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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). |
| 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 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). |
Countries
China
Contacts
Primary ContactShengliang Chen
Outcome results
None listed