Gastrointestinal DiseasesNCT05572593
Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
A study testing Pharmacogenomics (PGx) genetic testing in people with Gastrointestinal Diseases, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Pharmacogenomics (PGx) genetic testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Pharmacogenomics (PGx) genetic testing
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomics (PGx) genetic testingGenetic
A buccal swab to collect cells from the inside the cheek
| Study group | Role | What they receive |
|---|---|---|
| Guided Group | Experimental | Subjects treating physician will receive PGx results to facilitate clinical decisions Receives: Genetic: Pharmacogenomics (PGx) genetic testing |
| Unguided Group | Active comparator | Subjects treating physician will be blinded to PGx results and will receive standard medical care Receives: Genetic: Pharmacogenomics (PGx) genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
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
Measured: Baseline, 3 months. 6 months
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)
Measured: Baseline, 3 months. 6 months
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".
Measured: Baseline, 3 months. 6 months
Secondary outcomes (4)
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
Measured: Baseline, 3 months, 6 months
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
Measured: Baseline, 3 months, 6 months
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
Measured: Baseline, 3 months, 6 months
Change in Pain score
Measured using the self-reported McGill Pain score; score range 0-78; higher scores indicate worse pain
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start8 Feb 2018
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adil Bharucha, MBBS, MD, Mayo Clinic
- Investigators
- Adil Bharucha, MBBS, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572593
- Sponsor's protocol ID
- 16-008401
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pharmacogenomic Testing in Patients With Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT05572593
- Acronym / sponsor ID
- 16-008401
- Conditions
- Gastrointestinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Group | Experimental | Genetic: Pharmacogenomics (PGx) genetic testingSubjects treating physician will receive PGx results to facilitate clinical decisions |
| Unguided Group | Active comparator | Genetic: Pharmacogenomics (PGx) genetic testingSubjects treating physician will be blinded to PGx results and will receive standard medical care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomics (PGx) genetic testingA buccal swab to collect cells from the inside the cheek | Genetic | Guided Group, Unguided Group |
Primary outcome
Number of subjects to have clinical management changes based on PGx results
Time frame: 3 months
Number of subjects that pharmacogenomic (PGx) results guided the clinical management of gastrointestinal disorders
Change in Irritable Bowel Syndrome (IBS) severity
Time frame: 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
Change in Irritable Bowel Syndrome Quality of Life
Time frame: 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
Time frame: 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".
4 secondary outcomes
Change in anxiety
Time frame: Baseline, 3 months, 6 months
Change in Patient Health Questionnaire Score
Time frame: Baseline, 3 months, 6 months
Change in general well-being
Time frame: Baseline, 3 months, 6 months
Change in Pain score
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil Bharucha, MBBS, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomics (PGx) genetic testing in people with Gastrointestinal Diseases, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects to have clinical management changes based on PGx results (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.