Clinical trial NCT05719168: 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
Overall status: UNKNOWN
Phase: NA
Conditions: GERD
Lead sponsor: The Functional Gut Clinic
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, cross-sectional
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Difference in BSGM parameters between GORD and healthy controls
timeFrame: 24-hours
measure: Difference in BSGM parameters between GORD and healthy controls
timeFrame: 24-hours
measure: Difference in BSGM parameters between GORD and healthy controls
timeFrame: 24-hours
measure: Difference in BSGM parameters between GORD and healthy controls
timeFrame: 24-hours
measure: Difference in BSGM parameters between GORD and healthy controls
timeFrame: 24-hours
Secondary outcomes:
measure: Normal reference ranges for gastric emptying and BSGM
timeFrame: 24-hours
measure: Correlate reflux event frequency with Gastric Alimetry Rhythm Index
timeFrame: 24-hours
measure: Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)
timeFrame: 24-hours
measure: Correlate reflux event frequency with Fed:Fasted Amplitude ratio
timeFrame: 24-hours
measure: Correlate reflux event frequency with Average Amplitude
timeFrame: 24-hours
measure: Correlate reflux event frequency with % of retrograde activity
timeFrame: 24-hours
measure: Correlate symptom severity with BSGM parameters
timeFrame: 24-hours
measure: Correlate quality of life with BSGM parameters
timeFrame: 24-hours
measure: Correlate the results of gastric emptying with BSGM parameters
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with BSGM parameters
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index
timeFrame: 24-hours
measure: Correlate the results of oesophageal manometry with % of retrograde activity
timeFrame: 24-hours
measure: Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index
timeFrame: 7 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Functional Gut Clinic
state: Greater Manchester
Study officials:
References: