Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

NCT ID: NCT05572593

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2021-09-15

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.

Conditions

Gastrointestinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Guided Group

Subjects treating physician will receive PGx results to facilitate clinical decisions

Group Type: EXPERIMENTAL

Pharmacogenomics (PGx) genetic testing

Intervention Type: GENETIC

A buccal swab to collect cells from the inside the cheek

Unguided Group

Subjects treating physician will be blinded to PGx results and will receive standard medical care

Group Type: ACTIVE_COMPARATOR

Pharmacogenomics (PGx) genetic testing

Intervention Type: GENETIC

A buccal swab to collect cells from the inside the cheek

Interventions

Pharmacogenomics (PGx) genetic testing

A buccal swab to collect cells from the inside the cheek

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adil Bharucha, MBBS, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adil Bharucha, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

16-008401

Identifier Type: -

Identifier Source: org_study_id