A Study to Learn More about How Individuals Process Specific Medications Based on Their Genes in Patients with Gastrointestinal Disorders

Overview

Información sobre este estudio

The purpose of this study is to:

  1. To evaluate the pharmacogenomic profile (PGx) by genotyping 22 genes, including the CYP2D6 genotype, in patients with functional GI disorders.
  2. To assess the impact of PGx testing on prescriber patterns in this practice.
  3. To explore the impact of PGx testing on patient outcomes after an assessment in this practice.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Age 18-75 years old.
  • 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Adil Bharucha, M.B.B.S., M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20347862

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