IBS-C Questionnaire Study

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

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Constipation; Functional Constipation

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Guangzhou, China, 510062
    • Research Site
  • Guangzhou, China, 510530
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Wenzhou, China
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Zhengzhou, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

With the ratio of IBS-C/non-IBS-C as 1:1, when the sample size is 300, assuming the sensitivity and specificity using ROME IV as reference are 0.85 and 0.85 respectively, a two-sided 95% confidence interval will produce confidence interval widths of 0.12 and 0.12 respectively.

In addition, with the same assumption as above, a total sample size of 300 (which includes 150 subjects with the IBS-C) achieves 99% power to detect a change in sensitivity/ specificity from 0.7 to 0.85 using a two-sided binomial test. The target significance level is 0.05.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
IBS-C Group; Result of ROME VI marked as 'IBS-C'.
Non IBS-C Group; Result of ROME VI marked as 'Non IBS-C'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients	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%	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the accuracy of the Simplified Diagnosis Tool	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%	14 month
the Kappa coefficient of the Simplified Diagnosis Tool	The Kappa coefficient will be calculated according to the following formula: Kappa coefficient=(P0-Pe)/(1-Pe)	14 months
the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool	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%	14 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Peking University First Hospital; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Nanchang University; First Affiliated Hospital, Sun Yat-Sen University; Shengjing Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Ruijin Hospital; Henan Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Wuhan Union Hospital, China
• Investigators: Principal Investigator: Lishou Xiong, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: IBS-C; functional constipation; diagnosis, questionnaire
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation
• Other Study ID Numbers: D5630R00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No