Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001721190
Ethics application status
Approved
Date submitted
5/11/2019
Date registered
6/12/2019
Date last updated
15/09/2021
Date data sharing statement initially provided
6/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the effect of host and food factors on carbohydrate fermentation by healthy adult human gut bacteria
Scientific title
An in vitro study to investigate the fermentability, microbial composition and metabolite production of healthy adult human gut microbiota, according to human breath methane excretion, with different dietary carbohydrates
Secondary ID [1] 299723 0
Nil known
Universal Trial Number (UTN)
U1111-1243-0188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy adults- gut microbiome composition 315068 0
Condition category
Condition code
Diet and Nutrition 313402 313402 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Health screening questionnaire - single session completed via email, takes approximately 10 minutes
2. Collection of breath sample for analysis of breath gases, single 20 minute session (occurring Dec-Jan 2019/2020. Approx 2-4 weeks after health screening questionnaire).
3. 3 day food and hydration diary, 10 minutes per day for 3 consecutive days immediately prior to faecal sample donation (approx 1-10 weeks after breath sample)
4. Collection of faecal sample used to seed ex-vivo (in-vitro) fermentation laboratory model, single 20 minute session (occurring Jan-Feb 2020 i.e. 1-10 weeks after initial breath sample)
Note: All breath samples will be taken from all participants in a 2-3 week timeframe. After all breath samples have been processed, participants will be asked to provide faecal samples (1-2 person per week) for the following 8 weeks. Faecal samples must be used fresh for the ex-vivo work, and the laboratory setup for the experiment takes approximately 1 week.
Intervention code [1] 315985 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321882 0
Breath methane concentration as assessed by a breath sample and laboratory analysis
Timepoint [1] 321882 0
Single collection after participant recruitment
Primary outcome [2] 321948 0
Faecal microbial communities identified by shotgun metagenomic sequencing of faecal sample
Timepoint [2] 321948 0
Single timepoint, collection of faecal sample after participant recruitment
Secondary outcome [1] 376575 0
Participant health status as assessed by a health screening questionnaire. Questionnaire was designed specifically for this study, using NZ Blood Donor Session Record (2017) and the Cornell University Biological Agent Reference Sheet for Human Feces and Urine (2017) as a basis for the questions.
Timepoint [1] 376575 0
One online health screening questionnaire during participant recruitment

Eligibility
Key inclusion criteria
Medically healthy (according to exclusion criteria listed below)
BMI between 18.5 and 30
Long term consumption of a moderate-high fibre diet (at least 15 g/day)
Happy to provide a 3-day food and hydration diary
Happy to complete a general health screening questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
According to a health screening questionnaire:
Some current health concerns
Previously diagnosed with norovirus, hepatitis A or intestinal parasite (ever)
Currently experiencing any flu-like symptoms (fever, headache, dehydration, weight loss, lethargy)
Noticed blood in faeces over the last 3 months
Previously diagnosed with Salmonella, Shigella, Yersinia, Campylobacter, Aeromonas, Candida, E.coli, Klebsiella, Cryptosporidium, Entamoeba histolytics (ever)
Somebody in the household has had diarrhoea, vomiting, stomach pain or upset stomach in the last 3 months
Experienced gastrointestinal symptoms over the last 3 months (loss of appetite, nausea, vomiting, diarrhoea)
Taken medicines over the last 2 weeks excluding contraception
Used antibiotics or laxatives in the last 3 months
According to the Bristol Stool Chart, most common type of stool is rated 1 or 7
In a typical day, defecate less than 1 time per day

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/12/2019
Date of last participant enrolment
Anticipated
2/03/2020
Actual
30/10/2020
Date of last data collection
Anticipated
30/06/2021
Actual
30/10/2020
Sample size
Target
20
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 22010 0
New Zealand
State/province [1] 22010 0
Manawatu

Funding & Sponsors
Funding source category [1] 304193 0
University
Name [1] 304193 0
Riddet Institute/Massey University
Country [1] 304193 0
New Zealand
Primary sponsor type
University
Name
Riddet Institute
Address
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 304425 0
None
Name [1] 304425 0
Address [1] 304425 0
Country [1] 304425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304663 0
Massey University Human Ethics Committee
Ethics committee address [1] 304663 0
Ethics committee country [1] 304663 0
New Zealand
Date submitted for ethics approval [1] 304663 0
29/01/2019
Approval date [1] 304663 0
08/04/2019
Ethics approval number [1] 304663 0
Southern A, Application 19/03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97770 0
Miss Laura Payling
Address 97770 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country 97770 0
New Zealand
Phone 97770 0
+642041931406
Fax 97770 0
Email 97770 0
[email protected]
Contact person for public queries
Name 97771 0
Laura Payling
Address 97771 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country 97771 0
New Zealand
Phone 97771 0
+642041931406
Fax 97771 0
Email 97771 0
[email protected]
Contact person for scientific queries
Name 97772 0
Laura Payling
Address 97772 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country 97772 0
New Zealand
Phone 97772 0
+642041931406
Fax 97772 0
Email 97772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data on methane breath gas concentration, food diaries and faecal microbial communities will be shared after de-identification. It will be shared as data underlying published results.
When will data be available (start and end dates)?
Immediately following publication, with no end date.
Available to whom?
Anyone with access to the peer reviewed journal with which the data is published.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Supplementary materials on the Journal access site.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5547Informed consent form    378678-(Uploaded-12-11-2019-12-50-37)-Study-related document.pdf
5548Ethical approval    378678-(Uploaded-05-11-2019-13-28-20)-Study-related document.pdf



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.