Comparison of gut transit measurements for the Atmo Gas Capsule with the Smart Pill

Not Applicable

Recruiting

• Conditions: Gastrointestinal function; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12619001219178
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-03
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Healthy volunteers without known gastrointestinal conditions

Exclusion Criteria

Pregnancy, body mass index >27 kg/m2, previous abdominal surgery, history of gastrointestinal,endocrine or neurogenic disorders known to influence gastrointestinal motility (including Crohn's disease, diverticulosis, bowel obstruction), swallowing difficulties, receiving diathermy, implantable devices such as a pacemaker, antibiotic, pre-, probiotic use in the last 4 weeks, radiation enteritis, gastric bezoar, suspected or known strictures and current participation in other trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for Atmo Gas Capsule to reaches the ileo-caecal junction, indicated by fall in measured oxygen concentration, compared to that of gold standard (Smartpill). This comparison is one time measurement and the primary outcome. [Estimated between 1-2 days post ingestion of capsules.]

Secondary Outcome Measures

Name	Time	Method
Comparison of whole gut transit (time from ingestion) between the Atmo Gas Capsule and Smartpill, indicated by loss of signal to receiver after a bowel motion. [Estimated 1-2 days post ingestion of capsules]