A combined data gathering and diagnostic test accuracy study to test the feasibility of using an acoustic belt for differential diagnosis of gastrointestinal diseases and disorders.

The University of Western Australia0 个研究点目标入组 365 人开始时间: 2020年8月31日最近更新: 2020年9月21日

适应症

试验速览

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•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).

•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.

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