Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Change in Irritable Bowel Syndrome (IBS) severity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Change in Irritable Bowel Syndrome (IBS) severity
时间窗: 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
时间窗: 3 months
Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders
Change in Irritable Bowel Syndrome Quality of Life
时间窗: 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
时间窗: 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".
次要结局
- Change in anxiety(Baseline, 3 months, 6 months)
- Change in Patient Health Questionnaire Score(Baseline, 3 months, 6 months)
- Change in general well-being(Baseline, 3 months, 6 months)
- Change in Pain score(Baseline, 3 months, 6 months)
研究者
Adil Bharucha, MBBS, MD
Principal Investigator
Mayo Clinic