Gastrointestinal Symptom Questionnaire Validation
April 28, 2021 updated by: University of East Anglia
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
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 Type
Observational
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
As above
Description
Inclusion Criteria:
- As above Either healthy or GI disease or non-GI disease
Exclusion Criteria:
- Unable to provide informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy
Volunteers over 18 years
|
Form filling only
|
|
Gastrointestinal disorders
Over 18 and with any gastrointestinal or liver disorder
|
Form filling only
|
|
Non-gastrointestinal disorders
Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease
|
Form filling only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Construct validity measured by Validation of new score
Time Frame: 18 months
|
Validation of new score
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Alastair Forbes, MD, UEA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2020
Primary Completion (Actual)
November 3, 2020
Study Completion (Actual)
November 3, 2020
Study Registration Dates
First Submitted
July 31, 2015
First Submitted That Met QC Criteria
July 31, 2015
First Posted (Estimate)
August 3, 2015
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.