Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
NCT ID: NCT05134584
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
78 participants
INTERVENTIONAL
2021-01-01
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Linaclotide
290μg once daily, 4 weeks
Omeprazol
20mg twice daily for the first 10 days
Itopride
50mg three times daily for the first 10 days
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.
Lactulose
20mL once daily, 4 weeks
Omeprazol
20mg twice daily for the first 10 days
Itopride
50mg three times daily for the first 10 days
Interventions
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Linaclotide
290μg once daily, 4 weeks
Lactulose
20mL once daily, 4 weeks
Omeprazol
20mg twice daily for the first 10 days
Itopride
50mg three times daily for the first 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
3. Pregnancy
18 Years
75 Years
ALL
Yes
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Shengliang Chen
professor,chief physician
Principal Investigators
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Shengliang Chen
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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RenJiH
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shengliang Chen
Role: primary
References
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Cheng L, Wang Q, Wu B, Yan X, Xu P, Qiu H, Chen S. Efficacy of Linaclotide in Functional Dyspepsia and Constipation-Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial. J Gastroenterol Hepatol. 2025 May;40(5):1119-1127. doi: 10.1111/jgh.16925. Epub 2025 Mar 13.
Other Identifiers
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RenJiH211012
Identifier Type: -
Identifier Source: org_study_id