Irritable Bowel Syndrome With ConstipationNCT04968652
IBS-C Questionnaire Study
An observational study of Irritable Bowel Syndrome With Constipation and Functional Constipation, run by AstraZeneca at 10 sites in China.
Trial summary
The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation, Functional Constipation
- How many people
- 300 participants
- Where
- 10 sitesChina
- Study dates
- 1 Nov 2021to 28 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
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- ≥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'.
Who cannot join
- 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.)
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- Any history of colon surgeries.
- Individuals who participate in any interventional study currently.
- Not suitable for the study judged by investigators.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Research Site
Beijing
Research Site
Guangzhou, 510062
Research Site
Guangzhou, 510530
Research Site
Nanchang, 330006
Research Site
Nanjing
Research Site
Shanghai
Research Site
Shenyang
Research Site
Wenzhou
Research Site
Wuhan, 430022
Research Site
Zhengzhou
About this study
Official title: Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
Read the 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.
- Keywords
- IBS-C; functional constipation; diagnosis, questionnaire
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS-C Group | Result of ROME VI marked as 'IBS-C'. | |
| Non IBS-C Group | Result of ROME VI marked as 'Non IBS-C' |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 14 months
Secondary outcomes (3)
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%
Measured: 14 month
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)
Measured: 14 months
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%
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Nov 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, The First Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University First Hospital, The First Affiliated Hospital of Anhui Medical University, Shengjing Hospital
- Responsible party
- Sponsor
- Investigators
- Lishou Xiong, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968652
- Sponsor's protocol ID
- D5630R00002
- Status last verified
- Dec 2023
- First submitted
- 28 Jun 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
- ClinicalTrials.gov ID
- NCT04968652
- Acronym / sponsor ID
- D5630R00002
- Keywords
- IBS-C; functional constipation; diagnosis, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Ruijin Hospital, The First Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Peking University First Hospital, The First Affiliated Hospital of Anhui Medical University, Shengjing Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS-C Group | – | –Result of ROME VI marked as 'IBS-C'. |
| Non IBS-C Group | – | –Result of ROME VI marked as 'Non IBS-C' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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'.
Key exclusion criteria (9 listed)
- 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:
- Individuals who participate in any interventional study currently.
- Not suitable for the study judged by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
3 secondary outcomes
the accuracy of the Simplified Diagnosis Tool
Time frame: 14 month
the Kappa coefficient of the Simplified Diagnosis Tool
Time frame: 14 months
the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lishou Xiong principal investigator
First Affiliated Hospital, Sun Yat-Sen University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome With Constipation and Functional Constipation, run by AstraZeneca at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.