IBS-C Questionnaire Study

AstraZeneca

Status: Completed

Conditions: Functional Constipation; Irritable Bowel Syndrome With Constipation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04968652

D5630R00002

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

IBS-C Group

Description:

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

Non IBS-C Group

Description:

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