Clinical trial NCT04968652: IBS-C Questionnaire Study
Official title: Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome With Constipation
Functional Constipation
Keywords: IBS-C; functional constipation; diagnosis, questionnaire
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Ruijin Hospital
name: The First Affiliated Hospital of Nanchang University
name: Henan Provincial People's Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Wuhan Union Hospital, China
name: Peking University First Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Shengjing Hospital
First posted: 2021-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients
timeFrame: 14 months
Secondary outcomes:
measure: the accuracy of the Simplified Diagnosis Tool
timeFrame: 14 month
measure: the Kappa coefficient of the Simplified Diagnosis Tool
timeFrame: 14 months
measure: the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool
timeFrame: 14 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Lishou Xiong
role: PRINCIPAL_INVESTIGATOR
References: