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Completed

NCT Number: NCT04968652

IBS-C Questionnaire Study

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

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Key information

Conditions

Irritable Bowel Syndrome With Constipation Disease Functional Constipation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients

    Time frame: 14 months

    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%

Secondary outcomes

  1. the accuracy of the Simplified Diagnosis Tool

    Time frame: 14 month

    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%

  2. the Kappa coefficient of the Simplified Diagnosis Tool

    Time frame: 14 months

    The Kappa coefficient will be calculated according to the following formula:

    Kappa coefficient=(P0-Pe)/(1-Pe)

  3. the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool

    Time frame: 14 months

    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%

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • 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
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2021
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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