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Trial registered on ANZCTR


Trial ID
ACTRN12616000507482
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
20/04/2016
Date last updated
23/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Human gas capsule clinical trial study on healthy volunteers
Scientific title
Evaluation of a novel medical device entitled "human gas capsule" to obtain a real-time gas profile of the gastrointestinal tract in healthy adult volunteers
Secondary ID [1] 288904 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal gas in healthy people aged between 18 and 55 298240 0
Condition category
Condition code
Oral and Gastrointestinal 298379 298379 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The day before commencing the formal clinical trial, three standardised meals will be provided to the participant.
The following day the investigators will then provide the participants thecapsule to swallow with a standardised meal and a specific carbohydrate syrup drink. The two groups will be split into absorbable carbohydrate syrup (glucose) and fermentable carbohydrate syrup (inulin). A range of quantities from 1.25 g to 40 g mixed in 200 mL of water will be tested on smaller subsets within the two groups. An external data acquisition system will also be provided and attached around the participant’s waist for most of the time after the capsule intake. This is a small handheld receiver that receives the transmission from the capsule, strores the data locally on a SD card and is Bluetooth linked to a smart phone. The smart phone will be provided to display the GI gas data and temperature in real-time. Subsequently, the investigators will measure and record participants’ temperature, heart rate, blood pressure and exhaled gas concentration by blowing into a breath analyser, which will provide necessary data for analysis.
Afterward, the investigators will transport the participants to the appointed hotel. The hotel is at least 3 and half star to assure their comfort. The participants can socialise with each other and have a relaxed and enjoyable time in the hotel with low key physical activities, such as walking, eating, reading, watching TV and so on. The participant will need to collect his/her stool sample with the provided flushable faecal collection sheet and container, and provide it to the investigators to check if the capsule has been excreted. The investigators assess the microbial communities that may colonise on the surface of the excreted capsule using conventional sequencing methods such as 16S rRNA. The investigators will be on site but make regular visits to the participants to check their health condition and measure their body temperature, heart rate, blood pressure and exhaled gas concentration. The participant will need to stay in the hotel for two days during the formal clinical trial. All the food and drink will be provided by the investigators to ensure the consistence of diet.

human gas capsule:

Capsule components: the main components of the human gas capsules are similar to the components of the commercial camera and pH capsules in the market. The difference is that the pH sensor or camera is replaced by gas sensors and gas permeable membranes. The main components include: safe and low current silver oxide batteries, electronic boards, gas sensors, gas permeable membranes and the bio compatible shell of the capsule.
Intervention code [1] 294367 0
Early detection / Screening
Comparator / control treatment
Low fibre group acts as the comparator.
Control group
Active

Outcomes
Primary outcome [1] 297852 0
Gas profile, assessed using the human gas capsule
Timepoint [1] 297852 0
Assessed every 5 minutes from ingestion of capsule to 32 hours post ingestion
Primary outcome [2] 297853 0
Accessibility and reliability of the user interface for the data acquisition system assessed by 5-point Likert Scale. This is a composite outcome.
Timepoint [2] 297853 0
Assessed at 32 hours post ingestion of capsule
Secondary outcome [1] 322445 0
Investigation of the capsule transient time in the bowel of healthy volunteers by recording the passage time when they appear in the stool
Timepoint [1] 322445 0
Assessed daily up to 9 days after intake
Secondary outcome [2] 322466 0
The effect of normal diet on the gas profile of each volunteer using human gas capsules
Timepoint [2] 322466 0
2 days after the intake of human gas capsule by the volunteer

Eligibility
Key inclusion criteria
Men and women aged between 18 and 55 years living independently in the community and who consider themselves in good health.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
First 12 participants will receive the low fibre diet, and the second 12 participants will receive the high fibre diet.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The raw data of the intestinal gas profile are extracted against time. They are then converted into meaningful gas concentration values in volume percentage (vol%) or part per million (ppm) based on the pre-calibration results of the human gas capsule before the clinical trial. The meal intake time will be plotted in the profile for result interpretation. Possible identification of gas types and concentrations in different sections of gastrointestinal tract will be analysed based on the previously reported in vivo and in vitro studies.
The plan is to have equal number of male and female participants (12 + 12) and we hope that this number gives us an acceptable baseline in our measurements (measurements on gas constituents of the gut by Levitt et al. (Gastroenterology, vol. 59, pp. 921-929, (1970)) used a total of less than 15 participants – so our chosen of 24 number will result in a better statistical outcome). No formal sample size calculation was performed,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293255 0
Government body
Name [1] 293255 0
National Health and Medical Research Council (NHMRC) Development Grant
Address [1] 293255 0
Level 1, 16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 293255 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
124 La Trobe Street Melbourne VIC 3001
Country
Australia
Secondary sponsor category [1] 292058 0
None
Name [1] 292058 0
None
Address [1] 292058 0
None
Country [1] 292058 0
Other collaborator category [1] 278924 0
University
Name [1] 278924 0
Monash University
Address [1] 278924 0
Level 6 99 Commercial Rd Prahran VIC 3004
Country [1] 278924 0
Australia
Other collaborator category [2] 278925 0
Hospital
Name [2] 278925 0
The Alfred Hospital
Address [2] 278925 0
99 Commercial Road Prahran VIC 3004
Country [2] 278925 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294734 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 294734 0
Ground Floor, Court Building Nepean Hospital, P.O. Box 63, Penrith NSW 2751
Ethics committee country [1] 294734 0
Australia
Date submitted for ethics approval [1] 294734 0
17/11/2015
Approval date [1] 294734 0
23/03/2016
Ethics approval number [1] 294734 0
Study 15/64- HREC/15/NEPEAN/128

Summary
Brief summary
This study aims to obtain a real-time gas profile of the entire gastrointestinal tract of healthy human volunteers on a standardised diet using a novel medical device entitled “human gas capsule”. The clinical trial will also evaluate the viability of the gas capsule in the human body, accessibility of the graphical user interface for the data acquisition system and the reliability of the data analysis.
Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 64866 0
Prof Kourosh Kalantar-zadeh
Address 64866 0
RMIT University, 124 La Trobe Street Melbourne VIC 3001
Country 64866 0
Australia
Phone 64866 0
+61 3 9925 3254
Fax 64866 0
Email 64866 0
kourosh.kalantar@rmit.edu.au
Contact person for public queries
Name 64867 0
Prof Kourosh Kalantar-zadeh
Address 64867 0
RMIT University, 124 La Trobe Street Melbourne VIC 3001
Country 64867 0
Australia
Phone 64867 0
+61 3 9925 3254
Fax 64867 0
Email 64867 0
kourosh.kalantar@rmit.edu.au
Contact person for scientific queries
Name 64868 0
Prof Kourosh Kalantar-zadeh
Address 64868 0
RMIT University, 124 La Trobe Street Melbourne VIC 3001
Country 64868 0
Australia
Phone 64868 0
+61 3 9925 3254
Fax 64868 0
Email 64868 0
kourosh.kalantar@rmit.edu.au