None listed
Conditions
Brief summary
Irritable bowel syndrome (IBS) is a gut function disorder which causes chronic pan, bloating, diarrhoea and constipation. IBS affects 11% of the world’s population and is notoriously difficult to diagnose, because it causes no obvious structural changes. Experts recommend use of the Rome IV questionnaire about symptoms to diagnose IBS, but this gives a lot of false negatives, and is not commonly used. Typically doctors diagnose IBS by ruling out other gastrointestinal diseases with similar symptoms using colonoscopies. These are costly and invasive and still don’t provide a positive diagnosis for IBS, which leaves patients confused and reluctant to start treatment. We have developed an acoustic belt and associated software that analyses gut noises. This allows us to tell apart people with healthy guts and IBS with high accuracy. However, IBS diagnosis also involves differentiation between IBS and organic diseases, with similar symptoms. The objective of this study is to develop and test the differential diagnosis capabilities of the acoustic belt. We will collect gut sound recordings from patients with coeliac disease, Crohn’s disease and ulcerative colitis at the time of diagnosis by gastroenterologists. We will then use features from the sound recordings to build optimal models (software) that characterise the conditions. We will then test the accuracy of these models with a new set of study participants. Again, these participants will be patients newly referred to gastroenterologists by GPs or Emergency Departments for investigation of lower abdominal symptoms. All will undertake the reference standard: clinical investigations, pathology tests and scoping to arrive at a diagnosis. This is arrived at as part of routine care. They will also undertake the sound recording test (with the technicians and sound analysts blind to their condition). The results of the reference standard and the sound test will be compared to arrive at measures of accuracy for the sound test. The project is a key step in assessing the feasibility of a sound based, non-invasive approach for screening for organic disease and IBS diagnosis.
Interventions
Sound Recordings
All participants will undergo a single session of recordings with the acoustic belt. The intervention is the same for both stages of the study: the data gathering and the diagnostic test accuracy study. Further, the intervention is also the same for participants with all conditions: irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and coealiac disease. The sound recordings take place within three weeks of the initial endoscopic review that forms part of the r
Sound Recordings All participants will undergo a single session of recordings with the acoustic belt. The intervention is the same for both stages of the study: the data gathering and the diagnostic test accuracy study. Further, the intervention is also the same for participants with all conditions: irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and coealiac disease. The sound recordings take place within three weeks of the initial endoscopic review that forms part of the reference standard. The participants fast overnight (no food from 9pm, no water except to take medications from midnight) and commence the recordings at around 9am. They sit and wear the belt whilst bowel sounds are recorded, first for 2 hours and then for 40 minutes after a short break of no more than 15 minutes. At the start of the second recording they consume a standard meal consisting of a (low–lactose SUSTAGEN (Registered Trademark) OPTIMUM (Trademark) shake and small glass of water). Participants may read, or surf the internet whilst wearing the belt. Our acoustic belt, worn around the abdomen, consists of four sensor heads with microphones held in place by a soft Tubigrip (Registered Trademark) bandage. The sensors are attached to a recording unit with a very low voltage battery. These belts have previously been used safely and effectively for another study to gather data and test a model for differentiation between IBS and healthy gut sounds. The recorded sounds are then transferred to a desktop for analysis. The recordings are processed to remove background noise, plus heart and breathing sounds and speech. The bowel sounds are extracted and then physical features of the bowel sounds. Rome IV Criteria At the time of recordings, all participants will also complete a diagnostic questionnaire, The Rome IV criteria, which consists of six multi-choice questions about their abdominal symptoms. The intervention is administered by a trained member of the team who aids with fitting of the belt, timing of recordings, provision of the Rome IV questionnaire, plus meal preparation and provision. To monitor adherence and data quality, all stages of the intervention are recorded are checked off on a tick-sheet and recordings are checked for quality (i.e. duration and all sensors recording) prior to processing and analysis.
Sponsors
The University of Western Australia
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Outcome results
None listed