Atmo Gas capsule localisation study in healthy volunteers
Not Applicable
- Conditions
- Gastrointestinal dysmotilityOral and Gastrointestinal - Normal oral and gastrointestinal development and function
- Registration Number
- ACTRN12620000535976
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Healthy controls without known gastrointestinal disease/disorder
Exclusion Criteria
history of gastrointestinal, endocrine or neurological disorders known to influence gastrointestinal motility, dysphagia, presence of suspected strictures, radiation enteritis or gastric bezoar; pregnancy; individuals with a body mass index >30 kg/m2, those with previous abdominal surgery (except appendicectomy) or implantable devices such as a pacemaker; antibiotic, prebiotic or probiotic use in the last 4 weeks; intake of proton pump inhibitors, H2 receptor antagonists, antacids in the last 7 days or prokinetics in the last 2 days; those who are currently receiving diathermy or have planned MRI or diathermy in the next 2 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (a) confirmation of gastric emptying landmark using a composite of<br>(i) the time at which the first gradient inflection for the motility marker was recorded in the stomach (verified visually via graphs generated by the Atmo data receiver) AND <br>(ii) the times that direct visualisation of the capsule disappeared from the stomach/entered the duodenum on sonographic imaging.<br>[Estimated within 4 h after ingestion of the Atmo capsule];(b) confirmation of ileal-caecal junction using a composite of <br>(i) the time at which a second gradient inflection for the O2-equivalent motility marker was recorded after gastric emptying and no further temperature drop associated with water ingestion have occurred<br>AND <br>(b) the time via sonographic imaging that direct visualisation of the capsule entered the caecum. <br>[Estimated within 6-8 h post-Atmo capsule ingestion]
- Secondary Outcome Measures
Name Time Method Gastric emptying time assessed by the Atmo capsule, defined as the duration between capsule ingestion and gastric emptying landmark and verified by sonographic images as the appearance of the capsule in the duodenum[Within 4 h post capsule ingestion];Whole gut transit time assessed by the Atmo capsule, defined as the duration between capsule ingestion and expulsion. [Within 24-48 h post-capsule ingestion];Small bowel transit times defined by duration between gastric emptying and proposed ileal-caecal junction as assessed using data from the Atmo capsule and verified by sonographic images. [Within 6-8 h];large bowel transit time defined as duration between ileal-caecal junction and passage of capsule as denoted by temperature drop or loss of signal coinciding with a bowel movement [Within 24-36 h]