The Noisy Guts Project: Can we use analysis of gut sounds to accurately diagnose different gut conditions?

Not Applicable

• Conditions: Irritable bowel syndrome; Crohn's disease; Ulcerative colitis; Coeliac disease; Oral and Gastrointestinal - Inflammatory bowel disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12620000864921
• Lead Sponsor: The University of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-31
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

Data gathering stage
Patients presenting for first investigation of lower gastrointestinal symptoms with a gastroenterologist, who receive a diagnosis of coeliac disease (confirmed via distal duodenal biopsy after positive serology), Crohn’s disease or ulcerative colitis (confirmed via Upper GI endoscopy, or colonoscopy or sigmoidoscopy and biopsy).

Diagnostic Test Accuracy study
Additional inclusion criteria for the DTA study: Patients presenting for first investigation of lower gastrointestinal symptoms with a gastroenterologist, who receive a diagnosis of IBS (confirmed through colonoscopy negative for organic disease), Crohn’s disease, colitis or coeliac disease (confirmed as above).

Exclusion Criteria

We will exclude participants with a learning disability of poor understanding of English, which means they are unable to provide informed consent or understand the Rome IV symptom criteria questions.

We will exclude individuals with a severe allergy to milk proteins (not lactose) or soy.

We will also exclude individuals who have been diagnosed with the following conditions: cancer anywhere in the GI tract, current infection of the GI tract, HIV infection, diabetes or an eating disorder. We will also exclude those with neurological disease or damage that may impair gastrointestinal motility. We will exclude individuals who are pregnant, who have undergone bariatric surgery or resection of any part of their bowels and those regularly taking high doses of NSAIDs or opiates. These factors all affect sounds from the abdomen.

Participants who cannot undertake the recording visit within 3 weeks from the gastroenterologist’s preliminary diagnosis or who fail to fast or complete recordings, e.g., due to displaying respiratory symptoms, will also be excluded.

In most cases the preliminary diagnosis will match the final diagnosis provided by the gastroenterologist. In rare cases the histology results may lead to a participant moving between gastrointestinal conditions or being excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified