Suspended
Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
What is being tested
Linaclotide
+ Omeprazol
+ Itopride
Drug
Who is being recruted
Colonic Diseases+7
+ Colonic Diseases, Functional
+ Constipation
From 18 to 75 Years
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: January 2021
Summary
Principal SponsorRenJi Hospital
Study ContactShengliang Chen
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2021
Actual date on which the first participant was enrolled.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 TitleEfficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
Principal SponsorRenJi Hospital
Study ContactShengliang Chen
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
78 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Colonic DiseasesColonic Diseases, FunctionalConstipationDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsIrritable Bowel Syndrome
Criteria
3 inclusion criteria required to participate
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)
3 exclusion criteria prevent from participating
Helicobacter Pylori infection
GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
Pregnancy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients 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.
Group II
Active ComparatorPatients 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
SuspendedOne Study Center