The Influence of Concomitant Irritable Bowel Syndrome on Gastro-Oesophageal Reflux Disease Symptoms and Severity.

NCT06615856 | Not Yet Recruiting

• 1 other identifier: GA24/167199
• Study Type: observational
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome; Gastro-oesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• IBS Subtype

  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.

  September 2024 - January 2025 (subject to change).

• Gastro-oesophageal Reflux Symptoms

  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.

  September 2024 - January 2025 (subject to change).

Secondary Outcomes (3)

• 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).

Study Arms (1)

Patients referred for high-resolution oesophageal manometry and multi-channel impedance pH testing

Patients that have been referred for high-resolution oesophageal manometry and multi-channel intraluminal impedance-pH monitoring at the Gastrointestinal Physiology department at Leeds Teaching Hospitals between September 2024 - January 2025 (subject to change based on recruitment time).

Other: Questionnaire

Interventions

Questionnaire OTHER

Two questionnaires will be provided to participants to complete before their routine tests (which they would already be having regardless of the study and are not affected by their participation in the study). The questionnaires include: A Gastro-Oesophageal Reflux Symptom Questionnaire; and the ROME-IV Diagnostic IBS Module Questionnaire

Patients referred for high-resolution oesophageal manometry and multi-channel impedance pH testing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The potential pool of participants includes those that have been routinely referred for high-resolution oesophageal manometry and ambulatory pH/multichannel intraluminal impedance-pH studies at the Gastrointestinal Physiology department at Leeds Teaching Hospitals NHS Trust from September 2024 to January 2025 (subject to change, depending on time of approval confirmation and recruitment time).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastroesophageal Reflux

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Kate Brownley, MSc Clinical Science

CONTACT

+441132064268; kate.brownley@nhs.net

Ella Moore, BSc Human Physiology

CONTACT

+447736564456; ella.moore5@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: October 14, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share