Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-10-01
2023-12-01
Brief Summary
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Participants will undergo BSGM for 4-hours in addition to high resolution manometry (HRM), pH-impedance monitoring, and gastric emptying breath test.
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patients with medical refractory GERD
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.
Body Surface Gastric Mapping
64-channel electrode array placed on the outer abdomen
Healthy controls without gastrointestinal symptoms
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.
Body Surface Gastric Mapping
64-channel electrode array placed on the outer abdomen
Interventions
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Body Surface Gastric Mapping
64-channel electrode array placed on the outer abdomen
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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The Functional Gut Clinic
OTHER
Responsible Party
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Dr Anthony Hobson
Clinical Director
Locations
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The Functional Gut Clinic
Manchester, Greater Manchester, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FGC-22-002
Identifier Type: -
Identifier Source: org_study_id
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