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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
97
A buccal swab to collect cells from the inside the cheek
Mayo Clinic Rochester
Rochester, Minnesota, United States
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
Time frame: 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
Time frame: 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)
Time frame: 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".
Time frame: Baseline, 3 months. 6 months
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
Time frame: Baseline, 3 months, 6 months
Change in Patient Health Questionnaire Score
Measured using the self-reported Patient Health Questionnaire (PHQ-9); score range 0-27 points, higher scores indicate worse symptoms
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Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months, 6 months