Search / Trial NCT06615856

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

Launched by THE LEEDS TEACHING HOSPITALS NHS TRUST · Sep 24, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

ClinConnect Summary

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 attr...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About The Leeds Teaching Hospitals Nhs Trust

The Leeds Teaching Hospitals NHS Trust is a prominent healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality patient care, innovative research, and advanced medical education. As a leading clinical trial sponsor, the Trust plays a pivotal role in facilitating cutting-edge research initiatives that aim to improve health outcomes and advance medical knowledge. With a multidisciplinary team of experts and access to state-of-the-art facilities, the Trust is dedicated to fostering collaboration and ensuring the highest ethical standards in clinical research, ultimately contributing to the development of new treatments and therapies for diverse patient populations.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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