IBS-C Questionnaire Study

NCT04968652 | Completed

• 1 other identifier: D5630R00002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Irritable Bowel Syndrome With Constipation; Functional Constipation

Keywords

IBS-C; functional constipation; diagnosis, questionnaire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the accuracy of the Simplified Diagnosis Tool

  14 month

• the Kappa coefficient of the Simplified Diagnosis Tool

  14 months

• the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool

  14 months

Study Arms (2)

IBS-C Group

Result of ROME VI marked as 'IBS-C'.

Non IBS-C Group

Result of ROME VI marked as 'Non IBS-C'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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'.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Ruijin Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Henan Provincial People's Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Peking University First Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Shengjing Hospital: collaborator

Study Sites (10)

Research Site

Beijing, China

Location

Research Site

Guangzhou, 510062, China

Location

Research Site

Guangzhou, 510530, China

Location

Research Site

Nanchang, 330006, China

Location

Research Site

Nanjing, China

Location

Research Site

Shanghai, China

Location

Research Site

Shenyang, China

Location

Research Site

Wenzhou, China

Location

Research Site

Wuhan, 430022, China

Location

Research Site

Zhengzhou, China

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lishou Xiong

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 20, 2021
• Study Start: November 1, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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
• 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.

Locations

CN (10)