Gastric Neuromuscular Function in GERD

The Functional Gut Clinic

Status: Enrolling

Conditions: GERD

Treatments: Device: Body Surface Gastric Mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT05719168

FGC-22-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients with medical refractory GERD

Experimental group

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.

Treatment:

Device: Body Surface Gastric Mapping

Healthy controls without gastrointestinal symptoms

Active Comparator group

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.

Treatment:

Device: Body Surface Gastric Mapping