Exploring the Role of Gastric Neuromuscular Function in the Pathophysiology of Proton Pump Inhibitor (PPI) Refractory Gastresophageal Reflux Disease (GERD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in BSGM parameters between GORD and healthy controls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Difference in BSGM parameters between GORD and healthy controls
时间窗: 24-hours
Gastric Alimetry Rhythm Index (Normal \>0.25)
次要结局
- 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 Fed:Fasted Amplitude ratio(24-hours)
- Correlate reflux event frequency with Prinicpal Gastric Frequency (cpm)(24-hours)
- Correlate reflux event frequency with % of retrograde activity(24-hours)
- Correlate symptom severity with BSGM parameters(24-hours)
- Correlate the results of gastric emptying with BSGM parameters(24-hours)
- Correlate reflux event frequency with Average Amplitude(24-hours)
- Correlate quality of life with BSGM parameters(24-hours)
- Correlate the results of oesophageal manometry with BSGM parameters(24-hours)
- Correlate the results of hydrogen and methane breath testing with Gastric Alimetry Rhythm Index(7 days)
- Correlate the results of oesophageal manometry with % of retrograde activity(24-hours)
- Correlate the results of oesophageal manometry with Gastric Alimetry Rhythm Index(24-hours)
- Correlate the results of oesophageal manometry with Prinicpal Gastric Frequency(24-hours)
研究者
Dr Anthony Hobson
Clinical Director
The Functional Gut Clinic