Trial Outcomes & Findings for Physiology of GERD and Treatment Response (NCT NCT04292470)

Last Updated: 2023-03-28

Results Overview

Change in the average daily GERD symptom severity score over a 7-day period from baseline to the last week of the study in the expanded vs. standard group. GERD symptom severity is based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe; higher scores signify worse symptoms). Possible score range = 0 - 12. Change score calculated as average score at 8 weeks minus average score at baseline. For statistical testing, we used a general linear model of post-GERD symptoms adjusted for baseline GERD symptoms and randomization assignment.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Time 0 (baseline) to 8 weeks

Results posted on

2023-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Visit A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
Overall Study STARTED	2	5
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Visit A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Physiology of GERD and Treatment Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Visit n=2 Participants A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit n=5 Participants A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).	Total n=7 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 2.1 • n=5 Participants	45.0 years STANDARD_DEVIATION 16.0 • n=7 Participants	45.4 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Average Daily GERD Symptom Severity	2.9 units on a scale STANDARD_DEVIATION 2.6 • n=5 Participants	4.3 units on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	3.9 units on a scale STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: Time 0 (baseline) to 8 weeks

Population: All enrolled participants who attended both baseline and 8 week follow-up visits.

Outcome measures

Outcome measures
Measure	Standard Visit n=2 Participants A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit n=4 Participants A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
Change in GERD Symptoms	0.6 units on a scale Standard Deviation 1.6	-1.7 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Time 0 (baseline) to 8 weeks.

Population: All enrolled participants with complete physiologic data for both the patient and physician.

Concordance in skin conductance response (SCR) between patient and physician was calculated using an established approach to create a single index value for the visit (baseline). Average slopes of the SCR were calculated in moving 5 second windows, offset by 1 second. Pearson correlations between time-locked patient and physician SCR slopes were calculated over successive 15 second windows. A single session index was calculated from the ratio of the sum of the positive correlations across the entire visit divided by the sum of the absolute value of the negative correlations across the entire visit. To reduce skew, the natural logarithm of the index was calculated. An index value of zero reflects equal positive and negative correlations, a value greater than zero reflects more concordance in SCR than not, while a value less than zero reflects less than 50% concordance. In the statistical analysis, we included change in GERD symptoms from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Standard Visit n=2 Participants A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit n=4 Participants A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change	0.02 natural log of the index value Standard Deviation 0.47	-2.2 natural log of the index value Standard Deviation 4.8

Adverse Events

Standard Visit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Expanded Visit

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Visit n=2 participants at risk A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.	Expanded Visit n=5 participants at risk A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient's temperament (e.g., shy, anxious, caring). Some of these questions address the patient's "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).
Gastrointestinal disorders chest pain	0.00% 0/2 • 8 weeks	20.0% 1/5 • 8 weeks
Immune system disorders Allergic reaction	0.00% 0/2 • 8 weeks	20.0% 1/5 • 8 weeks

Additional Information

Dr. Michelle Dossett

University of California Davis

Phone: 916-734-5367

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place