Back to resultsGastric Neuromuscular Function in GERD
Primary Purpose
GERD
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Body Surface Gastric Mapping
Sponsored by
About this trial
This is an interventional diagnostic trial for GERD
Eligibility Criteria
Healthy controls Inclusion Criteria: 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 Exclusion Criteria: 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 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 Inclusion Criteria Referred for 24-hour pH-impedance monitoring 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 Exclusion Criteria 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
Sites / Locations
- The Functional Gut ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with medical refractory GERD
Healthy controls without gastrointestinal symptoms
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Difference in BSGM parameters between GORD and healthy controls
Gastric Alimetry Rhythm Index (Normal >0.25)
Difference in BSGM parameters between GORD and healthy controls
Prinicpal Gastric Frequency (Normal: 2.65-3.35cpm)
Difference in BSGM parameters between GORD and healthy controls
Fed:Fasted Amplitude ratio (Normal: >1.08)
Difference in BSGM parameters between GORD and healthy controls
Average Amplitude (Normal: 20-70 microvolts)
Difference in BSGM parameters between GORD and healthy controls
% of retrograde activity
Secondary Outcome Measures
Normal reference ranges for gastric emptying and BSGM
T lag and T 1/2 time (minutes)
Correlate reflux event frequency with Gastric Alimetry Rhythm Index
Frequency of reflux events with Gastric Alimetry Rhythm Index
Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)
Frequency of reflux events with Prinicpal Gastric Frequency (cpm)
Correlate reflux event frequency with Fed:Fasted Amplitude ratio
Frequency of reflux events with Fed:Fasted Amplitude ratio
Correlate reflux event frequency with Average Amplitude
Frequency of reflux events with Average Amplitude (microvolts)
Correlate reflux event frequency with % of retrograde activity
Frequency of reflux events with % of retrograde activity
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
Correlate quality of life with BSGM parameters
Total symptom burden scores according to the PAGI-QOL with Gastric Alimetry Rhythm Index
Correlate the results of gastric emptying with BSGM parameters
T lag and T 1/2 (minutes) with ith Gastric Alimetry Rhythm Index
Correlate the results of oesophageal manometry with BSGM parameters
Distal contractile integral (mmHg.s.cm) with Gastric Alimetry Rhythm Index
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Integrated relaxation pressure (mmHg) with Gastric Alimetry Rhythm Index
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Integrated relaxation pressure (mmHg) with Prinicpal Gastric Frequency
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Integrated relaxation pressure (mmHg) with % of retrograde activity
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Gastric Alimetry Rhythm Index
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Prinicpal Gastric Frequency
Correlate the results of oesophageal manometry with % of retrograde activity
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with % of retrograde activity
Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index
Total gas production (AUC ppm) with Gastric Alimetry Rhythm Index
Full Information
NCT ID
NCT05719168
First Posted
August 30, 2022
Last Updated
January 31, 2023
Sponsor
The Functional Gut Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05719168
Brief Title
Gastric Neuromuscular Function in GERD
Official Title
Exploring the Role of Gastric Neuromuscular Function in the Pathophysiology of Proton Pump Inhibitor (PPI) Refractory Gastresophageal Reflux Disease (GERD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Functional Gut Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, cross-sectional
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with medical refractory GERD
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls without gastrointestinal symptoms
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Body Surface Gastric Mapping
Intervention Description
64-channel electrode array placed on the outer abdomen
Primary Outcome Measure Information:
Title
Difference in BSGM parameters between GORD and healthy controls
Description
Gastric Alimetry Rhythm Index (Normal >0.25)
Time Frame
24-hours
Title
Difference in BSGM parameters between GORD and healthy controls
Description
Prinicpal Gastric Frequency (Normal: 2.65-3.35cpm)
Time Frame
24-hours
Title
Difference in BSGM parameters between GORD and healthy controls
Description
Fed:Fasted Amplitude ratio (Normal: >1.08)
Time Frame
24-hours
Title
Difference in BSGM parameters between GORD and healthy controls
Description
Average Amplitude (Normal: 20-70 microvolts)
Time Frame
24-hours
Title
Difference in BSGM parameters between GORD and healthy controls
Description
% of retrograde activity
Time Frame
24-hours
Secondary Outcome Measure Information:
Title
Normal reference ranges for gastric emptying and BSGM
Description
T lag and T 1/2 time (minutes)
Time Frame
24-hours
Title
Correlate reflux event frequency with Gastric Alimetry Rhythm Index
Description
Frequency of reflux events with Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)
Description
Frequency of reflux events with Prinicpal Gastric Frequency (cpm)
Time Frame
24-hours
Title
Correlate reflux event frequency with Fed:Fasted Amplitude ratio
Description
Frequency of reflux events with Fed:Fasted Amplitude ratio
Time Frame
24-hours
Title
Correlate reflux event frequency with Average Amplitude
Description
Frequency of reflux events with Average Amplitude (microvolts)
Time Frame
24-hours
Title
Correlate reflux event frequency with % of retrograde activity
Description
Frequency of reflux events with % of retrograde activity
Time Frame
24-hours
Title
Correlate symptom severity with BSGM parameters
Description
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
Time Frame
24-hours
Title
Correlate quality of life with BSGM parameters
Description
Total symptom burden scores according to the PAGI-QOL with Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate the results of gastric emptying with BSGM parameters
Description
T lag and T 1/2 (minutes) with ith Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with BSGM parameters
Description
Distal contractile integral (mmHg.s.cm) with Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Description
Integrated relaxation pressure (mmHg) with Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Description
Integrated relaxation pressure (mmHg) with Prinicpal Gastric Frequency
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
Description
Integrated relaxation pressure (mmHg) with % of retrograde activity
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Description
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Gastric Alimetry Rhythm Index
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
Description
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with Prinicpal Gastric Frequency
Time Frame
24-hours
Title
Correlate the results of oesophageal manometry with % of retrograde activity
Description
Frequency of transient lower oesophageal sphincter relaxation (TLOSRs) with % of retrograde activity
Time Frame
24-hours
Title
Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index
Description
Total gas production (AUC ppm) with Gastric Alimetry Rhythm Index
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy controls
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Inclusion Criteria
Referred for 24-hour pH-impedance monitoring
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
Exclusion Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Hobson, PhD
Phone
01613027777
Email
anthony@thefunctionalgutclinic.com
Facility Information:
Facility Name
The Functional Gut Clinic
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M3 4BG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Haworth, BSc
Phone
01613027777
Email
jordan@functionalgutdiagnostics.com
First Name & Middle Initial & Last Name & Degree
Jordan J Haworth, BSc
First Name & Middle Initial & Last Name & Degree
Sam Treadway, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Gastric Neuromuscular Function in GERD
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