Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05134584

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Constipation-predominant Irritable Bowel Syndrome	Drug: Linaclotide Drug: Lactulose Drug: Omeprazol Drug: Itopride	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Participants and investigators were not masked to group assignment. An independent statistician was masked for the data analysis.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Linaclotide 290μg once daily, 4 weeks Other Names: Linzess Drug: Omeprazol 20mg twice daily for the first 10 days Drug: Itopride 50mg three times daily for the first 10 days
Active Comparator: 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.	Drug: Lactulose 20mL once daily, 4 weeks Other Names: Duphalac Drug: Omeprazol 20mg twice daily for the first 10 days Drug: Itopride 50mg three times daily for the first 10 days

Arm

Intervention/Treatment

Experimental: 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.

Drug: Linaclotide

290μg once daily, 4 weeks

Other Names:

Linzess

Drug: Omeprazol

20mg twice daily for the first 10 days

Drug: Itopride

50mg three times daily for the first 10 days

Active Comparator: 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.

Drug: Lactulose

20mL once daily, 4 weeks

Other Names:

Duphalac

Drug: Omeprazol

20mg twice daily for the first 10 days

Drug: Itopride

50mg three times daily for the first 10 days

Outcome Measures

Primary Outcome Measures

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

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 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 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).
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)