NCT05719168

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

August 30, 2022

Last Update Submit

January 31, 2023

Conditions

GERD

Outcome Measures

Primary Outcomes (5)

  • Difference in BSGM parameters between GORD and healthy controls

    Gastric Alimetry Rhythm Index (Normal \>0.25)

    24-hours

  • Difference in BSGM parameters between GORD and healthy controls

    Prinicpal Gastric Frequency (Normal: 2.65-3.35cpm)

    24-hours

  • Difference in BSGM parameters between GORD and healthy controls

    Fed:Fasted Amplitude ratio (Normal: \>1.08)

    24-hours

  • Difference in BSGM parameters between GORD and healthy controls

    Average Amplitude (Normal: 20-70 microvolts)

    24-hours

  • Difference in BSGM parameters between GORD and healthy controls

    % of retrograde activity

    24-hours

Secondary Outcomes (17)

  • Normal reference ranges for gastric emptying and BSGM

    24-hours

  • Correlate reflux event frequency with Gastric Alimetry Rhythm Index

    24-hours

  • Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)

    24-hours

  • Correlate reflux event frequency with Fed:Fasted Amplitude ratio

    24-hours

  • Correlate reflux event frequency with Average Amplitude

    24-hours

  • +12 more secondary outcomes

Study Arms (2)

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.

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.

Device: Body Surface Gastric Mapping

Interventions

Body Surface Gastric MappingDEVICE

64-channel electrode array placed on the outer abdomen

Healthy controls without gastrointestinal symptomsPatients with medical refractory GERD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Referred for 24-hour pH-impedance monitoring
  • Aged 18-70 years old
  • BMI 18-35
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Functional Gut Clinic

Manchester, Greater Manchester, M3 4BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Anthony Hobson, PhD

CONTACT

01613027777anthony@thefunctionalgutclinic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Prospective, cross-sectional
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director

Study Record Dates

First Submitted

August 30, 2022

First Posted

February 8, 2023

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)