Those With and Without Gastrointestinal DisordersNCT02514057
Gastrointestinal Symptom Questionnaire Validation
An observational study of Those With and Without Gastrointestinal Disorders, run by University of East Anglia.
Trial summary
Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Those With and Without Gastrointestinal Disorders
- What is being tested?
- Questionnaire
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to 3 Nov 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: As above
Who may be able to join
- As above Either healthy or GI disease or non-GI disease
Who cannot join
- Unable to provide informed consent
About this study
Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.
Read the detailed description
210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Form filling only
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Volunteers over 18 years Receives: Other: Questionnaire | |
| Gastrointestinal disorders | Over 18 and with any gastrointestinal or liver disorder Receives: Other: Questionnaire | |
| Non-gastrointestinal disorders | Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity measured by Validation of new score
Validation of new score
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startNov 2020 (estimated)
- Primary completion3 Nov 2020
- Study completion3 Nov 2020
Why it stopped: investigator emigrated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Those With and Without Gastrointestinal DisordersStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alastair Forbes, MD, Study chair, UEA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514057
- Sponsor's protocol ID
- 150725
- Status last verified
- Apr 2021
- First submitted
- 31 Jul 2015
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Symptom Questionnaire Validation
- ClinicalTrials.gov ID
- NCT02514057
- Acronym / sponsor ID
- 150725
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator emigrated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 3 Nov 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
Assessment of a new gastrointestinal symptom questionnaire in comparison to 2 well established and validated questionnaires that do not fully fit the requirements of an investigator concerned about gastrointestinal side effects in a patient without primary gastrointestinal disease.
Detailed description
210 subjects Healthy (n=70), ill with non-GI disease (n=70), with GI disease (n=70) Age above 18 COnsent after full explanation Each subject completes 3 questionnaires Glasgow Dyspepsia Score Gastrointestinal Symptom Rating Scale New score This is a total of 48 questions Analysis will seek to validate the new score. There is no other intervention and no risks are anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Other: QuestionnaireVolunteers over 18 years |
| Gastrointestinal disorders | – | Other: QuestionnaireOver 18 and with any gastrointestinal or liver disorder |
| Non-gastrointestinal disorders | – | Other: QuestionnaireOver 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (1 listed)
- As above Either healthy or GI disease or non-GI disease
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireForm filling only | Other | Gastrointestinal disorders, Healthy, Non-gastrointestinal disorders |
Primary outcome
Construct validity measured by Validation of new score
Time frame: 18 months
Validation of new score
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: Undecided
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.
Alastair Forbes, MD study chair
UEA
Questions about this trial
What is this clinical trial studying?
An observational study of Those With and Without Gastrointestinal Disorders, run by University of East Anglia.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Construct validity measured by Validation of new score (time frame: 18 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 4 May 2021.