IBS-C Questionnaire Study

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968652
• Other study ID #: D5630R00002
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: December 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Zhengzhou

Sponsors (11)

Lead Sponsor

Collaborator

AstraZeneca

First Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Peking University First Hospital, Ruijin Hospital, Shengjing Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Third Affiliated Hospital, Sun Yat-Sen University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   CSR Synopsis