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Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Primary Purpose

Gastrointestinal Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pharmacogenomics (PGx) genetic testing

About this trial

This is an interventional other trial for Gastrointestinal Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guided Group

Unguided Group

Arm Description

Subjects treating physician will receive PGx results to facilitate clinical decisions

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

Outcomes

Primary Outcome Measures

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

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

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)

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".

Secondary Outcome Measures

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

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

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

Change in Pain score

Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain

Full Information

NCT ID

NCT05572593

First Posted

October 5, 2022

Last Updated

October 5, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05572593

Brief Title

Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Official Title

Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

February 8, 2018 (Actual)

Primary Completion Date

September 15, 2021 (Actual)

Study Completion Date

September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Diseases

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Guided Group

Arm Type

Experimental

Arm Description

Subjects treating physician will receive PGx results to facilitate clinical decisions

Arm Title

Unguided Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Genetic

Intervention Name(s)

Pharmacogenomics (PGx) genetic testing

Intervention Description

A buccal swab to collect cells from the inside the cheek

Primary Outcome Measure Information:

Title

Number of subjects to have clinical management changes based on PGx results

Description

Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders

Time Frame

3 months

Title

Change in Irritable Bowel Syndrome (IBS) severity

Description

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

Title

Change in Irritable Bowel Syndrome Quality of Life

Description

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

Title

Change in symptom severity with dyspepsia

Description

Time Frame

Baseline, 3 months. 6 months

Secondary Outcome Measure Information:

Title

Change in anxiety

Description

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

Title

Change in Patient Health Questionnaire Score

Description

Measured using the self-reported Patient Health Questionnaire (PHQ-9); score range 0-27 points, higher scores indicate worse symptoms

Time Frame

Baseline, 3 months, 6 months

Title

Change in general well-being

Description

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

Title

Change in Pain score

Description

Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain

Time Frame

Baseline, 3 months, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adil Bharucha, MBBS, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

Mayo Clinic Clinical Trials

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Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders

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