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Gastrointestinal Symptom Questionnaire Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514057
Recruitment Status : Withdrawn (investigator emigrated)
First Posted : August 3, 2015
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of East Anglia

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Those With and Without Gastrointestinal Disorders Other: Questionnaire

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
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gastrointestinal Symptom Questionnaire Validation
Estimated Study Start Date : November 2020
Actual Primary Completion Date : November 3, 2020
Actual Study Completion Date : November 3, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy
Volunteers over 18 years
 Other: Questionnaire
Form filling only
Gastrointestinal disorders
Over 18 and with any gastrointestinal or liver disorder
 Other: Questionnaire
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
 Other: Questionnaire
Form filling only


Outcome Measures
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Primary Outcome Measures :
  1. Construct validity measured by Validation of new score [ Time Frame: 18 months ]
    Validation of new score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
As above
Criteria

Inclusion Criteria:

  • As above Either healthy or GI disease or non-GI disease

Exclusion Criteria:

  • Unable to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514057


Sponsors and Collaborators
University of East Anglia
Investigators
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Study Chair: Alastair Forbes, MD UEA
More Information
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Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT02514057    
Other Study ID Numbers: 150725
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases