Understanding the Influence of Concomitant Irritable Bowel Syndrome (IBS) on Gastro-Oesophageal Reflux Disease (GORD), Including GORD-related Symptoms, GORD Severity, Oesophageal Motility, and Multi-Channel Intraluminal Impedance-pH Findings.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 主要终点
- IBS Subtype
研究概览
简要总结
This research aims to investigate whether there is a link between irritable bowel syndrome (IBS) and acid reflux, particularly whether there is a difference in acid reflux symptoms between people with and without IBS.
IBS is a functional gastrointestinal disorder, which has the same root cause as other functional gastrointestinal disorders that produce symptoms similar to acid reflux. Acid reflux symptoms may be typical (heartburn, regurgitation) or atypical (cough, sore throat, chest pain).
All participants are given two questionnaires: one to categorise them as either IBS or non-IBS, and one to understand their acid reflux symptoms. From this, the project will investigate whether there is a difference in the type (typical/atypical) and severity of acid reflux symptoms between people with and without IBS that attend for diagnostic acid reflux testing at Leeds Teaching Hospitals.
Two factors determine how much acid reflux someone has: the ability of the oesophagus (food- pipe) to move food from the throat to the stomach, and how well the muscle between the oesophagus and stomach works to keep acidic contents from moving back up.
All participants will have a test to see how well the muscles in their oesophagus are working. As there may be a link between IBS and oesophageal function, this project will investigate whether any patterns of abnormal oesophageal function can be identified in IBS patients that might explain their acid reflux symptoms.
Participants will then have a test that measures acid reflux over 24 hours, including the amount of acid and non-acid coming up, how high this reaches in the oesophagus, and whether symptoms are linked to these events.
Analysing these test results against questionnaire answers might help to understand the link between IBS and acid reflux to improve future diagnosis and treatment for the many people that have these conditions.
详细描述
Functional gastrointestinal disorders (FGIDs) are characterised by chronic gastrointestinal symptoms in the absence of demonstrable pathology, diagnosed using the Rome-IV criteria. IBS is the most prevalent FGID, affecting >12% UK population, accounting for 40-60% gastroenterology outpatient referrals. It is characterised by abdominal pain, bloating, and altered stool form or frequency, and is classified into four subtypes: IBS with predominant constipation; predominant diarrhoea; mixed bowel habits; or unsubtyped.
Whilst IBS pathogenesis is not wholly understood, it is considered attributable to visceral hypersensitivity (VH), disordered microbiota-brain-gut axis communication, gastrointestinal infection, and brain function changes. VH is an altered sensation response to physiological stimuli, which may occur from nervous system disturbances. Non-pathological visceral functions should not result in pain, yet the disordered response to physiological stimuli with VH causes an enhanced perception of mechanical triggers applied to the bowel, inducing perceived discomfort.
Oesophageal FGIDs with similar VH-mediated pathogenesis include functional heartburn (FH), reflux hypersensitivity (RH), functional chest pain, and globus. These can produce symptoms that are phenotypically indistinguishable from gastro-oesophageal reflux disease (GORD), yet exhibit no measurable cause.
GORD results from retrograde movement of acidic gastric contents into the oesophagus, characterised by excessive oesophageal acid exposure (OAE). Protective physiological mechanisms minimise gastro-oesophageal reflux, namely the anti-reflux barrier, comprising the lower oesophageal sphincter (LOS), crural diaphragm and supporting structures, along with peristaltic clearance of refluxate from the oesophagus. However, compromise of these mechanisms may cause gastro-oesophageal reflux to increase to pathological levels of OAE, resulting in oesophagitis and symptom generation.
Ambulatory pH-monitoring directly confirms or refutes GORD diagnoses by measuring OAE and reflux episode frequency over 24-hours. GORD can be classified as erosive reflux disease (ERD), diagnosed endoscopically by erosive oesophagitis or Barrett's oesophagus, or non-erosive reflux disease (NERD) which presents with no mucosal damage.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that have been referred for high-resolution oesophageal manometry and ambulatory pH or multichannel intraluminal impedance-pH (MII-pH) studies at the Gastrointestinal Physiology department at Leeds Teaching Hospitals NHS Trust from September 2024 to January 2025 (dates subject to change depending on acquisition of approvals).
- •All participants must be fully consenting with a good understanding of what the study involves.
排除标准
- •Patients aged <18 years.
- •Those that have not followed the pre-test preparation criteria, including: those that have not been sufficiently fasted prior to testing (6 hours for food, 3 hours for drinks); those that have not retained from taking proton pump inhibitor medication for 7 days prior to testing (lansoprazole, omeprazole, esomeprazole, rabeprazole, pantoprazole), histamine-2 receptor antagonist medication for 2 days prior to testing (famotidine, cimetidine, nizatidine), and other antacids on the day of testing (Gaviscon, Rennies, Peptac, etc).
- •Patients that lack the capacity to understand, retain, and communicate information to accurately complete questionnaires relating to their experienced symptoms.
- •Non-consenting patients.
结局指标
主要结局
IBS Subtype
时间窗: September 2024 - January 2025 (subject to change).
Defined using the Rome-IV IBS module questionnaire, is necessary for grouping participants based on IBS symptoms and for building on previous research. The Rome-IV criteria is a well- established, verified tool for clinical diagnosis.
Gastro-oesophageal Reflux Symptoms
时间窗: September 2024 - January 2025 (subject to change).
The gastro-oesophageal reflux symptom questionnaire is suitable for assessing primary outcome measures of predominant symptom type, most bothersome symptom, and symptom severity. This is a valid for understanding participants' subjective perception of their symptoms and quantifies this with the use of closed questions.
次要结局
- Gastro-Oesophageal Reflux Disease Severity(September 2024 - January 2025 (subject to change).)
- Multi-Channel Intraluminal Impedance pH Findings(September 2024 - January 2025 (subject to change).)
- High-Resolution Oesophageal Manometry Findings(September 2024 - January 2025 (subject to change).)