NCT04968652

IBS-C Questionnaire Study

Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.

Detailed description

The potential study subject will be identified by the investigators by face-to-face visit, and there will be only 1 visit in this study. Every patient will complete both ROME IV and the Simplified Diagnosis Tool during the visit, and in the same day. The study will collect results of the ROME IV and the Simplified Diagnosis Tool. Sensitivity and specificity of simplified diagnosis methodology compared with ROME IV will be analysed after all the data has been collected.

Conditions

• Irritable Bowel Syndrome With Constipation
• Functional Constipation

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2021-07-20
• Last updated: 2023-12-28

Locations

10 sites across 1 country: China