GERDNCT05719168
Gastric Neuromuscular Function in GERD
A study testing Body Surface Gastric Mapping in people with GERD, run by The Functional Gut Clinic at 1 site in United Kingdom.
Trial summary
Bodysurface gastric mapping (BSGM) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- Body Surface Gastric Mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 1 Dec 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-70 years old
- BMI 18-35
- Able to understand written and spoken English
- Able to provide written consent
- Able to understand risks and benefits
- Referred for 24-hour pH-impedance monitoring
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- Aged 18-70 years old
- BMI 18-35
- Able to understand written and spoken English
- Able to provide written consent
- Able to understand risks and benefits
Who cannot join
- Antacid use (e.g. PPI, H2RA or Gaviscon) within last 12-months
- Active use of other medications known to impact gastric motility
- Upper GI symptoms including but not limited to heartburn, regurgitation, epigastric pain, nausea and bloating
- Significant medical condition
- History of skin allergies or hypersensitivity
- Active abdominal wounds or abrasions, fragile skin
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- Current pregnancy
- Vulnerable group e.g. prisoners/cognitive impairment/institutionalised individuals
- Regular cannabis users (unable to abstain for 7-days)
- Opioid user
- Unable to use a tablet device
- GORD patients
- Systemic or metabolic disorder known to cause gastric dysmotility other than diabetes (e.g. scleroderma, multiple sclerosis, hyperthyroidism).
- History of upper GI surgery or hiatal hernia (>5cm, paraesophageal, or 'large' on endoscopy report)
- Diabetic and on insulin
- Proven mechanical bowel obstruction
- History of skin allergies or hypersensitivity
- Active abdominal wounds or abrasions, fragile skin
- Current pregnancy
- Vulnerable group - prisoners/cognitive impairment/institutionalised individuals
- Regular cannabis users (unable to abstain for 7-days)
- Opioid user
- Unable to use a tablet device
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Functional Gut Clinic
Manchester, Greater Manchester, M3 4BG
Jordan Haworth, BSc, 01613027777, jordan@functionalgutdiagnostics.com
Jordan J Haworth, BSc
About this study
Official title: Exploring the Role of Gastric Neuromuscular Function in the Pathophysiology of Proton Pump Inhibitor (PPI) Refractory Gastresophageal Reflux Disease (GERD)
Bodysurface gastric mapping (BSGM) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (GERD).
Participants will undergo BSGM for 4-hours in addition to high resolution manometry (HRM), pH-impedance monitoring, and gastric emptying breath test.
Read the detailed description
This is a clinical trial of a non-invasive BSGM medical device (Gastric Alimetry) in patients with medical refractory GORD and healthy controls to determine the differences in gastric electrical activity, and correlate with adjacent measurements of gastro-esophageal function.
Patients referred to the Functional Gut Clinic for standard care investigation of GORD with HRM and pH-impedance monitoring will be recruited. Healthy volunteers will be recruited via advertisement.
All patients and healthy volunteers will undergo BSGM at the research site, which lasts around 4.5 hours. After a 0.5 hour baseline, subjects will undergo HRM and pH-impedance monitoring concomitantly. A test meal of porridge with C13 labelled octanoic acid will be consumed with BSGM and breath samples recorded for 4.0 hours after meal completion. The HRM catheter will be removed after 1.0 hour from finishing the test meal whist the pH-impedance monitoring will continue for the remainder of the site visit and for the remainder of the 24-hour study period whilst the subject is at home to quantify reflux.
- Conditions
- GERD
- Being tested
- Body Surface Gastric Mapping
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Surface Gastric MappingDevice
64-channel electrode array placed on the outer abdomen
| Study group | Role | What they receive |
|---|---|---|
| Patients with medical refractory GERD | Experimental | Participants undergo BSGM for 4.5 hours with simultaneous oesophageal manometry, pH-impedance monitoring and gastric emptying breath tests. Following completion, participants continue with ambulatory pH-impedance monitoring for a further 24-hours.
Participants undergo a hydrogen and emthane breath test on a seperate day. Receives: Device: Body Surface Gastric Mapping |
| Healthy controls without gastrointestinal symptoms | Active comparator | Participants undergo BSGM for 4.5 hours with simultaneous oesophageal manometry, pH-impedance monitoring and gastric emptying breath tests. Following completion, participants continue with ambulatory pH-impedance monitoring for a further 24-hours. Receives: Device: Body Surface Gastric Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in BSGM parameters between GORD and healthy controls
Gastric Alimetry Rhythm Index (Normal >0.25)
Measured: 24-hours
Difference in BSGM parameters between GORD and healthy controls
Prinicpal Gastric Frequency (Normal: 2.65-3.35cpm)
Measured: 24-hours
Difference in BSGM parameters between GORD and healthy controls
Fed:Fasted Amplitude ratio (Normal: >1.08)
Measured: 24-hours
Difference in BSGM parameters between GORD and healthy controls
Average Amplitude (Normal: 20-70 microvolts)
Measured: 24-hours
Difference in BSGM parameters between GORD and healthy controls
% of retrograde activity
Measured: 24-hours
Secondary outcomes (17)
Normal reference ranges for gastric emptying and BSGM
T lag and T 1/2 time (minutes)
Measured: 24-hours
Correlate reflux event frequency with Gastric Alimetry Rhythm Index
Frequency of reflux events with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)
Frequency of reflux events with Prinicpal Gastric Frequency (cpm)
Measured: 24-hours
Correlate reflux event frequency with Fed:Fasted Amplitude ratio
Frequency of reflux events with Fed:Fasted Amplitude ratio
Measured: 24-hours
Correlate reflux event frequency with Average Amplitude
Frequency of reflux events with Average Amplitude (microvolts)
Measured: 24-hours
Correlate reflux event frequency with % of retrograde activity
Frequency of reflux events with % of retrograde activity
Measured: 24-hours
Correlate symptom severity with BSGM parameters
Real time discrete (vomiting, belching, reflux counts) and continuous (Nausea, bloating, upper gut pain, heartburn, stomach burn and excessive fullness) gastrointestinal symptom scores at both pre- and post-prandial time periods determined by a series of multiple 10-point symptom severity scales integrated within the validated Gastric Alimetry iOS Application with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate quality of life with BSGM parameters
Total symptom burden scores according to the PAGI-QOL with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate the results of gastric emptying with BSGM parameters
T lag and T 1/2 (minutes) with ith Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate the results of oesophageal manometry with BSGM parameters
Distal contractile integral (mmHg.s.cm) with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Integrated relaxation pressure (mmHg) with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Integrated relaxation pressure (mmHg) with Prinicpal Gastric Frequency
Measured: 24-hours
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Integrated relaxation pressure (mmHg) with % of retrograde activity
Measured: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Gastric Alimetry Rhythm Index
Measured: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Prinicpal Gastric Frequency
Measured: 24-hours
Correlate the results of oesophageal manometry with % of retrograde activity
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with % of retrograde activity
Measured: 24-hours
Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index
Total gas production (AUC ppm) with Gastric Alimetry Rhythm Index
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, cross-sectional
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Functional Gut Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anthony Hobson, The Functional Gut Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719168
- Sponsor's protocol ID
- FGC-22-002
- Status last verified
- Jan 2023
- First submitted
- 30 Aug 2022
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Gastric Neuromuscular Function in the Pathophysiology of Proton Pump Inhibitor (PPI) Refractory Gastresophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT05719168
- Acronym / sponsor ID
- FGC-22-002
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Functional Gut ClinicUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (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.
Bodysurface gastric mapping (BSGM) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (GERD).
Participants will undergo BSGM for 4-hours in addition to high resolution manometry (HRM), pH-impedance monitoring, and gastric emptying breath test.
Detailed description
This is a clinical trial of a non-invasive BSGM medical device (Gastric Alimetry) in patients with medical refractory GORD and healthy controls to determine the differences in gastric electrical activity, and correlate with adjacent measurements of gastro-esophageal function.
Patients referred to the Functional Gut Clinic for standard care investigation of GORD with HRM and pH-impedance monitoring will be recruited. Healthy volunteers will be recruited via advertisement.
All patients and healthy volunteers will undergo BSGM at the research site, which lasts around 4.5 hours. After a 0.5 hour baseline, subjects will undergo HRM and pH-impedance monitoring concomitantly. A test meal of porridge with C13 labelled octanoic acid will be consumed with BSGM and breath samples recorded for 4.0 hours after meal completion. The HRM catheter will be removed after 1.0 hour from finishing the test meal whist the pH-impedance monitoring will continue for the remainder of the site visit and for the remainder of the 24-hour study period whilst the subject is at home to quantify reflux.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, cross-sectional
| Arm | Type | Receives |
|---|---|---|
| Patients with medical refractory GERD | Experimental | Device: Body Surface Gastric MappingParticipants undergo BSGM for 4.5 hours with simultaneous oesophageal manometry, pH-impedance monitoring and gastric emptying breath tests. Following completion, participants continue with ambulatory pH-impedance monitoring for a further 24-hours. Participants undergo a hydrogen and emthane breath test on a seperate day. |
| Healthy controls without gastrointestinal symptoms | Active comparator | Device: Body Surface Gastric MappingParticipants undergo BSGM for 4.5 hours with simultaneous oesophageal manometry, pH-impedance monitoring and gastric emptying breath tests. Following completion, participants continue with ambulatory pH-impedance monitoring for a further 24-hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-70 years old
- BMI 18-35
- Able to understand written and spoken English
- Able to provide written consent
- Able to understand risks and benefits
Key exclusion criteria (23 listed)
- Antacid use (e.g. PPI, H2RA or Gaviscon) within last 12-months
- Active use of other medications known to impact gastric motility
- Upper GI symptoms including but not limited to heartburn, regurgitation, epigastric pain, nausea and bloating
- Significant medical condition
- History of skin allergies or hypersensitivity
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 |
|---|---|---|
| Body Surface Gastric Mapping64-channel electrode array placed on the outer abdomen | Device | Healthy controls without gastrointestinal symptoms, Patients with medical refractory GERD |
Primary outcome
Difference in BSGM parameters between GORD and healthy controls
Time frame: 24-hours
Gastric Alimetry Rhythm Index (Normal >0.25)
Difference in BSGM parameters between GORD and healthy controls
Time frame: 24-hours
Prinicpal Gastric Frequency (Normal: 2.65-3.35cpm)
Difference in BSGM parameters between GORD and healthy controls
Time frame: 24-hours
Fed:Fasted Amplitude ratio (Normal: >1.08)
Difference in BSGM parameters between GORD and healthy controls
Time frame: 24-hours
Average Amplitude (Normal: 20-70 microvolts)
Difference in BSGM parameters between GORD and healthy controls
Time frame: 24-hours
% of retrograde activity
17 secondary outcomes
Normal reference ranges for gastric emptying and BSGM
Time frame: 24-hours
Correlate reflux event frequency with Gastric Alimetry Rhythm Index
Time frame: 24-hours
Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)
Time frame: 24-hours
Correlate reflux event frequency with Fed:Fasted Amplitude ratio
Time frame: 24-hours
Correlate reflux event frequency with Average Amplitude
Time frame: 24-hours
Correlate reflux event frequency with % of retrograde activity
Time frame: 24-hours
Correlate symptom severity with BSGM parameters
Time frame: 24-hours
Correlate quality of life with BSGM parameters
Time frame: 24-hours
Correlate the results of gastric emptying with BSGM parameters
Time frame: 24-hours
Correlate the results of oesophageal manometry with BSGM parameters
Time frame: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Time frame: 24-hours
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Time frame: 24-hours
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Time frame: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Time frame: 24-hours
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Time frame: 24-hours
Correlate the results of oesophageal manometry with % of retrograde activity
Time frame: 24-hours
Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Surface Gastric Mapping in people with GERD, run by The Functional Gut Clinic at 1 site in United Kingdom.
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 11 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Hobson, PhD (01613027777, anthony@thefunctionalgutclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in BSGM parameters between GORD and healthy controls (time frame: 24-hours). The study lists 5 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 8 Feb 2023.