Gastrointestinal Symptom Questionnaire Validation

NCT ID: NCT02514057

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-11-03

Brief Summary

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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

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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.

Conditions

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Those With and Without Gastrointestinal Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-gastrointestinal disorders

Over 18 and with any medical condition requiring hospital attention in which there is no primary gastrointestinal or liver disease

Questionnaire

Intervention Type OTHER

Form filling only

Healthy

Volunteers over 18 years

Questionnaire

Intervention Type OTHER

Form filling only

Gastrointestinal disorders

Over 18 and with any gastrointestinal or liver disorder

Questionnaire

Intervention Type OTHER

Form filling only

Interventions

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Questionnaire

Form filling only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alastair Forbes, MD

Role: STUDY_CHAIR

UEA

Other Identifiers

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150725

Identifier Type: -

Identifier Source: org_study_id

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