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Trial registered on ANZCTR


Registration number
ACTRN12622000422729
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
14/03/2022
Date last updated
7/07/2023
Date data sharing statement initially provided
14/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Suitability of an alternative nutrient bar for assessment of regional gastrointestinal transit using the Atmo gas-sensing capsule
Scientific title
Suitability of an alternative nutrient bar for assessment of regional gastrointestinal transit using the Atmo gas-sensing capsule in healthy individuals
Secondary ID [1] 306577 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal motility 325475 0
Condition category
Condition code
Oral and Gastrointestinal 322857 322857 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will involve consumption of two nutrient bars (alternative and predicate) on separate occasions. These bars are matched for serve size (~70 g) and nutritional composition (~1050 kJ, ~15 g protein, ~2 g fat, ~45 g carbohydrate), but differ in their ingredient profiles and in the proprietary processes by which they are manufactured. A medical device, the Atmo gas-sensing capsule, will be ingested immediately afterward, on each occasion.

Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology at the Alfred Centre to undertake the investigation. Participants will be asked to consume the alternative nutrient bar with 200 mL water within a 15 min timeframe, followed immediately by ingestion of the Atmo gas-sensing capsule. Participants will fast for the next 6 hours, and consume their normal meals thereafter. Participants will be monitored for 15 minutes before being able to leave the trial site.

Once ingested, the Atmo gas-sensing capsule transmits information about gas profiles (hydrogen, carbon dioxide etc.) and temperature every 5 minutes to an external receiver worn by the participant. Data recording will then be ceased once the capsule has been passed (confirmed visually in the toilet bowl or signal loss after a bowel movement) from the body. The Atmo gas-sensing capsule is a simple, safe and non-invasive method for learning about the inside of the bowel.

As a crossover trial, participants will undertake both treatments. The treatments will be delivered by a research dietitian from the Department of Gastroenterology. There is no minimum wash out period between treatments, although confirmation of the first capsule's excretion is required prior to the undertaking the second treatment.

Participants will be required to attend the trial site (Department of Gastroenterology at the Alfred Centre) once per treatment; each visit will take approximately 30 minutes.
Intervention code [1] 323008 0
Diagnosis / Prognosis
Comparator / control treatment
Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology at the Alfred Centre to undertake the investigation. Participants will be asked to consume the predicate nutrient bar with 200 mL water within a 15 min timeframe, followed immediately by ingestion of the Atmo gas-sensing capsule. Participants will fast for the next 6 hours, and consume their normal meals thereafter. Participants will be monitored for 15 minutes before being able to leave the trial site.
Control group
Active

Outcomes
Primary outcome [1] 330639 0
Gastric emptying time as measured via the Atmo gas-sensing capsule.
Timepoint [1] 330639 0
Estimated within 1-2 days post ingestion of capsules.
Secondary outcome [1] 407057 0
Small intestinal transit time as measured via the Atmo gas-sensing capsule.
Timepoint [1] 407057 0
Estimated within 1-2 days post ingestion of capsules.
Secondary outcome [2] 407058 0
Colonic transit time as measured via the Atmo gas-sensing capsule.
Timepoint [2] 407058 0
Estimated within 1-2 days post ingestion of capsules.
Secondary outcome [3] 407061 0
Whole gastrointestinal transit time as measured via the Atmo gas-sensing capsule.
This is a composite outcome (aggregate of gastric emptying time, small intestinal transit time and colonic transit time).
Timepoint [3] 407061 0
Estimated within 1-2 days post ingestion of capsules.
Secondary outcome [4] 407186 0
Gastrointestinal symptoms assessed via 100 mm visual analogue scale.
Timepoint [4] 407186 0
Assessed daily for a 3-day period following enrolment (baseline) and each day following capsule ingestion until confirmation of passing (treatments).
Secondary outcome [5] 407187 0
Palatability of nutrient bars, assessed via 100 mm visual analogue scale.
Timepoint [5] 407187 0
Once per treatment, during meal consumption/capsule ingestion.

Eligibility
Key inclusion criteria
Healthy individuals
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Presence or suspicion of gastrointestinal or chronic comorbidity (e.g., irritable bowel syndrome, chronic kidney disease).
- Have had previous abdominal surgery.
- Has an implantable device (e.g., pacemaker).
- Dysphagia to solid foods.
- Use of antibiotic therapies in the month preceding study commencement.
- Consumption of prebiotics and probiotics in the month preceding study commencement.
- Use of medication that potentially affects gastrointestinal transit time (e.g.,hypomotility agents, laxatives).
- Pregnancy or planning pregnancy.
- Current smoker.
- Unable to give written informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via online randomisation software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2022
Actual
16/03/2022
Date of last participant enrolment
Anticipated
29/04/2022
Actual
8/04/2022
Date of last data collection
Anticipated
Actual
21/04/2022
Sample size
Target
15
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36929 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 310909 0
Commercial sector/Industry
Name [1] 310909 0
Atmo Biosciences Ltd
Country [1] 310909 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 312198 0
None
Name [1] 312198 0
Address [1] 312198 0
Country [1] 312198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310471 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 310471 0
Room 111, Chancellery Building D
26 Sports Walk, Clayton Campus Research Office
Monash University
Clayton, VIC 3800
Ethics committee country [1] 310471 0
Australia
Date submitted for ethics approval [1] 310471 0
25/01/2022
Approval date [1] 310471 0
02/03/2022
Ethics approval number [1] 310471 0

Summary
Brief summary
A novel medical device, the Atmo gas-sensing capsule, has emerged as a technique capable of reliably assessing regional gastrointestinal transit time.

In order to standardise assessments made using the Atmo gas-sensing capsule, the meal that is eaten as part of the investigation needs to be consistent across assessments. An alternative nutrient bar has been developed for this purpose to approximate the nutrition profile and form of a predicate nutrient bar.

This study aims to compare how the two nutrient bars impact regional gastrointestinal transit time, to determine whether the newly developed, alternative nutrient bar is suitable for future evaluations of transit time using the Atmo gas-sensing capsule.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117782 0
Prof Peter Gibson
Address 117782 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 117782 0
Australia
Phone 117782 0
+61 3 9903 0271
Fax 117782 0
Email 117782 0
[email protected]
Contact person for public queries
Name 117783 0
Daniel So
Address 117783 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 117783 0
Australia
Phone 117783 0
+61 3 9903 0264
Fax 117783 0
Email 117783 0
[email protected]
Contact person for scientific queries
Name 117784 0
Daniel So
Address 117784 0
Department of Gastroenterology
Central Clinical School
Level 6 - The Alfred Centre
99 Commercial Road
Melbourne, VIC 3004
Country 117784 0
Australia
Phone 117784 0
+61 3 9903 0264
Fax 117784 0
Email 117784 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be only be available via manuscript for publication in a peer-reviewed journal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.