Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Not Applicable

Completed

• Conditions: Gastrointestinal Diseases
• Interventions: Genetic: Pharmacogenomics (PGx) genetic testing

• Registration Number: NCT05572593
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to learn more about how individuals break down and process specific medications based on their genes. Pharmacogenomics (PGx) is a new, specialized field within individualized medicine. PGx is the study of how genes may affect the body's response to, and interaction with, some prescription medications. Genes carry information that determines things such as eye color and blood type. Genes can also influence how individuals process and respond to medications. Depending on genetic make-up, some medications may work faster or slower or produce fewer side effects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-02-08
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

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Exclusion Criteria

• Patients who decline to be evaluated by a mental health professional during their evaluation.
• Rumination syndrome, cannabinoid hyperemesis syndrome, patients with a significant GI disease process (e.g., intestinal pseudo-obstruction, severe gastroparesis, megacolon) which, in the opinion of the investigator, is likely irreversible.
• Patients who, in the opinion of the investigator, are likely to undergo another major therapeutic intervention during the next 6 months (e.g., surgery or pelvic floor retraining by biofeedback therapy). However, other changes (e.g., medications) will not preclude participation in the study.
• Patients with any of the following per history, and review of medical record prior to study entry: any psychotic disorders, bipolar disorders, or major cognitive disorders; any active substance use disorders, other than tobacco; currently active suicidal ideation; current treatment with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS); discharge from a psychiatric inpatient hospital or intensive psychiatric outpatient program within 6 weeks prior to GI consultation.
• Patients who are unwilling or cannot, for any reason, adjust their medications.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Group	Pharmacogenomics (PGx) genetic testing	Subjects treating physician will receive PGx results to facilitate clinical decisions
Unguided Group	Pharmacogenomics (PGx) genetic testing	Subjects treating physician will be blinded to PGx results and will receive standard medical care

Primary Outcome Measures

Name	Time	Method
Change in Irritable Bowel Syndrome (IBS) severity	Baseline, 3 months. 6 months	Measured using the self-reported IBS severity scoring system (IBS-SSS) Questionnaire; 500 point continuous scale: 0= no symptoms to 500=maximum severity
Number of subjects to have clinical management changes based on PGx results	3 months	Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders
Change in Irritable Bowel Syndrome Quality of Life	Baseline, 3 months. 6 months	Measured using the self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) survey; score ranges from 0 (poor QOL) to 100 (maximum QOL)
Change in symptom severity with dyspepsia	Baseline, 3 months. 6 months	Measured using the self-reported Nepean Dyspepsia Index (NDI) questionnaire which consists of a symptom checklist that measures frequency (0-4), intensity (0-5) and bothersomeness (0-4) of 15 upper gastrointestinal symptoms. The average score for each symptom is derived by averaging scores for frequency, intensity, and bothersomeness. Scores of 3 respectively represent a frequency of 9 to 12 days/week, moderate intensity, and a bothersomeness of "quite a bit".

Secondary Outcome Measures

Name	Time	Method
Change in anxiety	Baseline, 3 months, 6 months	Measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) questionnaire; score range 0-21 points, higher scores indicate worse symptoms
Change in Patient Health Questionnaire Score	Baseline, 3 months, 6 months	Measured using the self-reported Patient Health Questionnaire (PHQ-9); score range 0-27 points, higher scores indicate worse symptoms
Change in general well-being	Baseline, 3 months, 6 months	Measured using the self-reported Global Wellbeing Likert scale; subjects asked to rate their general health perception on a scale range of 1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor
Change in Pain score	Baseline, 3 months, 6 months	Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States