GastroparesisNCT03896126
GI-Challenge Study for Gastroparesis Patients and Healthy Controls
An observational study of Gastroparesis, run by Stanford University at 1 site in United States.
Trial summary
Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Observational
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 18 Aug 2025
- Phase
- Observational
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.
Who may be able to join
- Male or female.
- Age 20-49 years old.
- Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
- Participant is capable of giving informed consent.
- Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
Who cannot join
- Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
- Surgical-related gastroparesis
- Extrinsic myopathy or neuropathy causing gastroparesis.
- Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
- Patients with enteric feeding tubes or requiring parenteral nutrition.
- Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment).
Show all 14Show fewer
- Untreated significant depression or suicidal thoughts.
- Pregnant or breast-feeding women.
- History of gastric pacemaker implantation.
- Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass.
- Patients with implantable electronic devices.
- Dairy, wheat, or egg allergy/intolerance.
- Allergy to commercial clinical adhesive for EKG stickers.
- Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Palo Alto, California, 94304
About this study
Official title: Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.
Read the detailed description
Impaired function of the vagus nerve has been documented in many chronic diseases such as diabetes, heart disease, and chronic pain, as well as gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease, and delayed stomach emptying (gastroparesis).
Current technology only allows for measurement of vagal nerve activity that regulates the heart and diagnostic tests focus specifically on cardiac vagal activity. Measuring vagal nerve activity as it pertains to the gastrointestinal system is an unmet medical need. Its importance will continue to grow since vagal nerve stimulation is being used increasingly in a myriad of different diseases, and currently there is no way of knowing if patients are getting too little or too much stimulation.
In this study, the gastrointestinal vagus nerve will be activated using normal stimulants like food ingestion and vagal activity will be measured using current non-invasive technology. Patients with gastroparesis and healthy controls will be asked to come in fasting, fill out surveys, and complete eating challenges while being connected to an autonomic function testing machine. Exploratory outcomes will also be measured - Participants will be connected to a Peripheral Intravenous Line in order to collect four vials of blood throughout the two hour clinic visit so that hormonal changes can be studied. Also, exploratory non-invasive electrogastrograms will be recorded remotely both during the autonomic function test and for three consecutive days as participants go about their daily lives.
The investigators' goal is to establish a protocol for measuring gastrointestinal evoked vagal activity and correlating activity with digestive function in both healthy people and gastroparesis patients.
- Conditions
- Gastroparesis
- Being tested
- Observational
- Keywords
- Healthy Control, Diabetic Gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
There is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis.
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis Patients | 20 gastroparesis patient ages 20-49 Receives: Other: Observational | |
| Healthy Controls | 40 healthy controls ages 20-49 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System.
The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.
Measured: Single two hour visit
Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.
The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.
Measured: Single two hour visit
Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.
To determine if sympathovagal scores correlate with gastroparesis clinical disease severity using standardized GI symptom scoring - the Gastroparesis Cardinal Symptom Index consists of 10 questions that rate gastroparesis symptoms on a scale of 1 - 6 from "none" to "very severe".
Measured: Single two hour visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jan 2019
- Primary completion2 Nov 2023
- Study completion18 Aug 2025
Why it stopped: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Nguyen, Stanford University
- Investigators
- Andres C Gottfried Blackmore, MD, PhD, Principal investigator, Stanford UniversityLinda Nguyen, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896126
- Sponsor's protocol ID
- 44258
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
- ClinicalTrials.gov ID
- NCT03896126
- Acronym / sponsor ID
- 44258
- Conditions
- Gastroparesis
- Keywords
- Healthy Control, Diabetic Gastroparesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 29 Mar 2019 (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.
Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.
Detailed description
Impaired function of the vagus nerve has been documented in many chronic diseases such as diabetes, heart disease, and chronic pain, as well as gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease, and delayed stomach emptying (gastroparesis).
Current technology only allows for measurement of vagal nerve activity that regulates the heart and diagnostic tests focus specifically on cardiac vagal activity. Measuring vagal nerve activity as it pertains to the gastrointestinal system is an unmet medical need. Its importance will continue to grow since vagal nerve stimulation is being used increasingly in a myriad of different diseases, and currently there is no way of knowing if patients are getting too little or too much stimulation.
In this study, the gastrointestinal vagus nerve will be activated using normal stimulants like food ingestion and vagal activity will be measured using current non-invasive technology. Patients with gastroparesis and healthy controls will be asked to come in fasting, fill out surveys, and complete eating challenges while being connected to an autonomic function testing machine. Exploratory outcomes will also be measured - Participants will be connected to a Peripheral Intravenous Line in order to collect four vials of blood throughout the two hour clinic visit so that hormonal changes can be studied. Also, exploratory non-invasive electrogastrograms will be recorded remotely both during the autonomic function test and for three consecutive days as participants go about their daily lives.
The investigators' goal is to establish a protocol for measuring gastrointestinal evoked vagal activity and correlating activity with digestive function in both healthy people and gastroparesis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis Patients | – | Other: Observational20 gastroparesis patient ages 20-49 |
| Healthy Controls | – | Other: Observational40 healthy controls ages 20-49 |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.
Key inclusion criteria (5 listed)
- Male or female.
- Age 20-49 years old.
- Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
- Participant is capable of giving informed consent.
- Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
Key exclusion criteria (14 listed)
- Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
- Surgical-related gastroparesis
- Extrinsic myopathy or neuropathy causing gastroparesis.
- Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
- Patients with enteric feeding tubes or requiring parenteral nutrition.
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 |
|---|---|---|
| ObservationalThere is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis. | Other | Gastroparesis Patients, Healthy Controls |
Primary outcome
Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System.
Time frame: Single two hour visit
The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.
Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.
Time frame: Single two hour visit
The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.
Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.
Time frame: Single two hour visit
To determine if sympathovagal scores correlate with gastroparesis clinical disease severity using standardized GI symptom scoring - the Gastroparesis Cardinal Symptom Index consists of 10 questions that rate gastroparesis symptoms on a scale of 1 - 6 from "none" to "very severe".
Results and safety
The study was stopped early (reason given: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- 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.
Andres C Gottfried Blackmore, MD, PhD principal investigator
Stanford University
Linda Nguyen, MD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by Stanford University 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 4 Sep 2025. 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 was stopped early (reason given: Study was stopped due to technical issues with the ANSAR equipment, lack of research personnel caused by COVID-19 restrictions imposed at our site, and recent departure of the PI and study chair from our research institute.). Results are not available in the source record.
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?
Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System. (time frame: Single two hour visit). The study lists 3 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 4 Sep 2025.