Clinical trial NCT05572593: Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
Official title: Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria

* Rome IV criteria for functional nausea and vomiting disorders (chronic nausea vomiting syndrome, cyclic vomiting syndrome), abdominal bloating/distention, dyspepsia, irritable bowel syndrome, chronic abdominal pain, functional diarrhea, or chronic constipation.
* On 1 or more medications identified in Appendix 1 on a daily basis for at least six months.
* Symptoms of moderate or severe severity on either of these 2 instruments: For IBS-SSS, use moderate (175-300) or severe (\> 300) IBS. For FD - Score ≥ 3 for any symptom on Nepean Dyspepsia Index.
* No prior pharmacogenomics assessment.
* Willingness to adjust medications based upon results of PGX testing.
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
* Patients must have the ability to complete questionnaires by themselves or with assistance.

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.

Primary outcomes:
measure: Number of subjects to have clinical management changes based on PGx results
timeFrame: 3 months
measure: Change in Irritable Bowel Syndrome (IBS) severity
timeFrame: Baseline, 3 months. 6 months
measure: Change in Irritable Bowel Syndrome Quality of Life
timeFrame: Baseline, 3 months. 6 months
measure: Change in symptom severity with dyspepsia
timeFrame: Baseline, 3 months. 6 months
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline, 3 months, 6 months
measure: Change in Patient Health Questionnaire Score
timeFrame: Baseline, 3 months, 6 months
measure: Change in general well-being
timeFrame: Baseline, 3 months, 6 months
measure: Change in Pain score
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adil Bharucha, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: