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A multi-center, prospective, real-world study of Linaclotide in the treatment of irritable bowel syndrome with predominant constipation

A multi-center, prospective, real-world study of Linaclotide in the treatment of irritable bowel syndrome with predominant constipation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052551
Enrollment
Unknown
Registered
2021-10-31
Start date
2020-09-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

case group:Nil

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients must voluntarily participate in this study, abide by the study regulations, understand and follow the follow-up plan, and correctly record medication, symptom assessment, and adverse events; 2. Chinese aged >= 18 years; 3. IBS-C patients meeting the Rome IV classification; 4. Suspension of other medications for constipation for 1 week.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from contraindications to linaclotide such as allergy to linaclotide or any excipients and known or suspected mechanical gastrointestinal obstruction; 2. Patients who are not expected to adhere to linaclotide alone; 3. Pregnant and lactating patients; 4. Patients participating in other clinical trials; 5. Patients who were considered unsuitable for other reasons.

Design outcomes

Primary

MeasureTime frame
defecation;abdominal symptom;IBS-SSS scale;Zung Self-Rating Anxiety Scale;the Self-Rating Depression Scale;the IBS quality of life questionnaire;

Countries

China

Contacts

Public ContactGuo Jianqiang

The Second Hospital of Shandong University

guo_jianqiang@126.com+86 15153169858

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026