IBS-C Questionnaire Study

Completed

• Conditions: Functional Constipation; Irritable Bowel Syndrome With Constipation

• Registration Number: NCT04968652
• Lead Sponsor: AstraZeneca

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-09
• Study First Posted: 2021-07-20
• Study Start: 2021-11-01
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Group 1 (IBS-C)

• ≥18 years old
• Decrease of frequency of bowel movement (<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
• With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
• Result of ROME VI marked as 'IBS-C'.

Group 2 (non-IBS-C)

• ≥18 years old
• Decrease of frequency of bowel movement (<3 time per week), change of stool consistency (stool that is hard and difficult to pass, Bristol Types 1 to 3), or other 'constipation symptoms' judged by investigators.
• With abdominal symptoms such as abdominal pain, bloating, and abdominal discomfort, or other 'constipation symptoms' judged by investigators.
• Result of ROME VI marked as 'Non IBS-C'.

Exclusion Criteria

• Individuals with a cognitive condition and unable to finish the questionnaire.

• Individuals have an acute or chronic non-GI condition that can be associated with constipation; e.g., central nervous system cause (Parkinson's disease, spinal cord injury, and multiple sclerosis), pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis.

• Individuals who had been diagnosed with the following organic health problems likely to affect GI symptoms:

  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • cancer anywhere in the GI tract or current infection of the GI tract.
  • Pelvic floor dysfunction. (i.e., disease that is not adequately treated or stable with therapy.)
  • Any history of colon surgeries.

• Individuals who participate in any interventional study currently.

• Not suitable for the study judged by investigators.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients	14 months	Sensitivity (%)=(number of patients judged as IBS-C based on both the Simplified Diagnosis Tool and the ROME IV)/( number of patients judged as IBS-C based on ROME IV) ×100% Specificity (%)=(number of patients judged as non-IBS-C based on both the Simplified Diagnosis Tool and ROME IV)/( number of patients judged as non-IBS-C based on The ROME IV) ×100%

Secondary Outcome Measures

Name	Time	Method
the accuracy of the Simplified Diagnosis Tool	14 month	Accuracy (%)=(number of patients judged as IBS-C based on both the Simplified Diagnosis Tool and The ROME IV + number of patients judged as non-IBS-C based on both Simplified Diagnosis Tool and The ROME IV) / (total number of patients in the FAS) ×100%
the Kappa coefficient of the Simplified Diagnosis Tool	14 months	The Kappa coefficient will be calculated according to the following formula: Kappa coefficient=(P0-Pe)/(1-Pe)
the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool	14 months	Positive predictive value (%)=(number of patients judged as IBS-C based on both Simplified Diagnosis Tool and The ROME IV)/(number of patients judged as IBS-C based on Simplified Diagnosis Tool) ×100% Negative predictive value (%)=(number of patients judged as non-IBS-C based on both Simplified Diagnosis Tool and The ROME IV)/( number of patients judged as non-IBS-C based on Simplified Diagnosis Tool) ×100%

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China