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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Group | Experimental | Subjects treating physician will receive PGx results to facilitate clinical decisions |
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| Unguided Group | Active Comparator | Subjects treating physician will be blinded to PGx results and will receive standard medical care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomics (PGx) genetic testing | Genetic | A buccal swab to collect cells from the inside the cheek |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects to have clinical management changes based on PGx results | Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders | 3 months |
| Change in Irritable Bowel Syndrome (IBS) severity | Measured using the self-reported IBS severity scoring system (IBS-SSS) Questionnaire; 500 point continuous scale: 0= no symptoms to 500=maximum severity | Baseline, 3 months. 6 months |
| Change in Irritable Bowel Syndrome Quality of Life | Measured using the self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) survey; score ranges from 0 (poor QOL) to 100 (maximum QOL) | Baseline, 3 months. 6 months |
| Change in symptom severity with dyspepsia | 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". | Baseline, 3 months. 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety | Measured using the self-reported Generalized Anxiety Disorder-7 (GAD-7) questionnaire; score range 0-21 points, higher scores indicate worse symptoms | Baseline, 3 months, 6 months |
| Change in Patient Health Questionnaire Score |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adil Bharucha, MBBS, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Measured using the self-reported Patient Health Questionnaire (PHQ-9); score range 0-27 points, higher scores indicate worse symptoms
| Baseline, 3 months, 6 months |
| Change in general well-being | 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 | Baseline, 3 months, 6 months |
| Change in Pain score | Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain | Baseline, 3 months, 6 months |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |