Human gas capsule clinical trial study on healthy volunteers

Not Applicable

Completed

• Conditions: Gastrointestinal gas in healthy people aged between 18 and 55; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12616000507482
• Lead Sponsor: RMIT University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Men and women aged between 18 and 55 years living independently in the community and who consider themselves in good health.

Exclusion Criteria

* Pregnant (for women only)
* Implantable device such as heart pacemaker
* Overweight (BMI > 27)
* Have a history of gastrointestinal disorders or disease
* Have a history of cardiovascular disease
* Have a history of kidney/liver/serious infections
* Have a history of diabetes or other hormone diseases
* Have a history of abdominal surgery
* A current smoker
* A current alcoholic (no more than two units of alcohol per day for men and no more than one unit per day for women)
* Currently suffering from a decreased appetite
* Currently suffering from nausea or vomiting
* Currently suffering from abdominal pain
* Currently suffering from light headedness, shakiness or weakness
* Currently suffering from any chronic condition
* Currently suffering from high blood pressure
* Current participation in a clinical trial involving taking a drug or another intervention)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gas profile, assessed using the human gas capsule<br>[Assessed every 5 minutes from ingestion of capsule to 32 hours post ingestion];Accessibility and reliability of the user interface for the data acquisition system assessed by 5-point Likert Scale. This is a composite outcome.[Assessed at 32 hours post ingestion of capsule]

Secondary Outcome Measures

Name	Time	Method
Investigation of the capsule transient time in the bowel of healthy volunteers by recording the passage time when they appear in the stool[Assessed daily up to 9 days after intake];The effect of normal diet on the gas profile of each volunteer using human gas capsules[2 days after the intake of human gas capsule by the volunteer ]