Gastrointestinal Symptom Questionnaire Validation

Those With and Without Gastrointestinal Disorders Clinical Trial

Official title:

Gastrointestinal Symptom Questionnaire Validation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02514057
• Other study ID #: 150725
• Status: Withdrawn
• Start date: November 2020
• Est. completion date: November 3, 2020

Study information

• Verified date: April 2021
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Those With and Without Gastrointestinal Disorders

Intervention

Other:
• Questionnaire
Form filling only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Construct validity measured by Validation of new score	Validation of new score	18 months