RecruitingACTRN12623000562673

Evaluation of Body Surface Gastric Mapping in a Multidisciplinary Integrated Care Pathway for Chronic Gastrointestinal Symptoms


Sponsor

Metro South Hospital and Health Service

Enrollment

62 participants

Start Date

Oct 1, 2024

Study Type

Interventional

Conditions

Summary

The aim of this research is to evaluate the potential role of Body Surface Gastric Mapping (Alimetry Ltd., New Zealand) in a multidisciplinary integrated care pathway for functional gastroduodenal disorders, to determine whether Body Surface Gastric Mapping test biomarkers are predictive of therapeutic response to a 12 week structured program of care. Hypotheses: Patients with neuromuscular disorders identified by BSGM will demonstrate reduced clinical response to an integrated care program incorporating psychological and behavioural interventions. Conversely, patients with normal BSGM tests will be more likely to respond to the integrated care program. They will also be more likely to also register reduced anxiety and depression scores.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at a non-invasive stomach mapping test called Body Surface Gastric Mapping (BSGM) for people with long-term, unexplained gut symptoms such as chronic nausea, bloating, or stomach pain. The BSGM test uses a wearable patch on the abdomen to measure electrical signals from the stomach — similar to how an ECG reads the heart — to detect whether the stomach's muscle activity is abnormal. Researchers want to find out whether your BSGM test result can predict how well you will respond to a 12-week integrated care program that combines medical, psychological, and behavioural support. The idea is that some gut problems are caused by nerve and muscle issues, while others respond better to stress management and therapy — and the BSGM test may help tell which is which. You may be eligible if you are 18 or older, have been referred to Princess Alexandra Hospital's gastroenterology integrated care clinic, and are prepared to complete the 12-week program. People who are pregnant or who have significant skin conditions or adhesive allergies on the stomach area would not be suitable.

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Interventions

The intervention will be the Multidisciplinary Integrated Care Clinic Treatment Approach (HREC/2021/QMS/75204). Participants will undergo a multidisciplinary review session for approximately 1 hour pr

The intervention will be the Multidisciplinary Integrated Care Clinic Treatment Approach (HREC/2021/QMS/75204). Participants will undergo a multidisciplinary review session for approximately 1 hour prior to receiving their personalised treatment plan by all potential specialists (i.e. gastroenterologist, general practitioner, psychologists, dieticians and physiotherapists). A 12 week structured program is targeted towards patients who have failed to respond to standard medical therapy, and includes both pharmacological and psychological interventions, as well as dietary and exercise consultations as required. Patient care in HREC/2021/QMS/75204 will be tailored to individual needs as identified by the treating multidisciplinary team, which may include: pharmacological management, psychological care (cognitive behaviour therapy / Acceptance and Commitment Therapy/ relaxation techniques / mindfulness), dietician consultation to avoid dietary triggers, and exercise programs including cardiorespiratory, resistance, flexibility, balance, and/or neuromotor training. The intervention by allied health (psychology, diet or exercise physiology) will be 1 hour a week for up to 12 weeks and will be delivered face to face or via telehealth. Adherence will be monitored via clinician assessment notes. The body surface gastric mapping (BSGM) procedure will be performed in accordance with established protocols [Varghese, 2022], within three weeks prior to subjects receiving their personalised treatment plans and will be performed by the clinical scientist. Before the BSGM test, medications affecting gastrointestinal motility will be discontinued for two days, and the intake of caffeine and nicotine will be avoided on the day of the test. An 8x8 electrode array, connected to a wearable reader, will be placed on the epigastric area. The BSGM test will consist of a 30-minute fasting period, a 10 minute test meal, and a subsequent four-hour postprandial period. Patients will be instructed to maintain a comfortable position, limit their movements, and document symptoms using the Gastric Alimetry App [Sebaratnam 2022]. Continuous symptoms like nausea, bloating, upper gut pain, heartburn, stomach burn, and excessive fullness will be recorded at a minimum of 15-minute intervals using 10-point Likert scales. Early satiation will be measured immediately after the meal with a similar scale, while episodic symptoms, such as reflux, belching, and vomiting, will be logged as distinct events [Sebaratnam 2022]. References: - Varghese C, et al. Normative Values for Body Surface Gastric Mapping Evaluations of Gastric Motility Using Gastric Alimetry: Spectral Analysis. Am J Gastroenterol. 2022 Dec 20. doi: 10.14309/ajg.0000000000002077. Epub ahead of print. PMID: 36534985. - Sebaratnam G, et al. Standardized system and App for continuous patient symptom logging in gastroduodenal disorders: Design, implementation, and validation. Neurogastroenterology & Motility 2022;34:e14331


Locations(1)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

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ACTRN12623000562673


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