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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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)
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

Study type
Patient registry
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

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

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
Both males and females
Can healthy volunteers participate?
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
Convenience sample
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 22010 0
New Zealand
State/province [1] 22010 0

Funding & Sponsors
Funding source category [1] 304193 0
Name [1] 304193 0
Riddet Institute/Massey University
Address [1] 304193 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country [1] 304193 0
New Zealand
Primary sponsor type
Riddet Institute
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
New Zealand
Secondary sponsor category [1] 304425 0
Name [1] 304425 0
Address [1] 304425 0
Country [1] 304425 0

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

Brief summary
The current project proposes to collect human faecal samples from healthy individuals, and use them to create an in vitro (ex-vivo) model of the colon.Participants will be asked to provide a breath sample to be analysed for methane concentration, and particpants will be divided into 2 groups; methane excretors and non-methane excretors. Different dietary fibres will be added to the model, and the characteristics of fermentation will be monitored. The main hypothesis is that the fermentation of dietary fibre will differ according to methane breath excretion by the faecal donor. This can help elucidate some of the individual differences between people that affect beneficial dietary fibre fermentation in the human colon.
Trial website
Trial related presentations / publications
Public notes

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
Fax 97770 0
Email 97770 0
Contact person for public queries
Name 97771 0
Miss Laura Payling
Address 97771 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country 97771 0
New Zealand
Phone 97771 0
Fax 97771 0
Email 97771 0
Contact person for scientific queries
Name 97772 0
Miss Laura Payling
Address 97772 0
Riddet Institute
Massey University
Private Bag 11 222
Palmerston North 4442
Country 97772 0
New Zealand
Phone 97772 0
Fax 97772 0
Email 97772 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 5547 0
Informed consent form
Citation [1] 5547 0
Link [1] 5547 0
Email [1] 5547 0
Other [1] 5547 0
Type [2] 5548 0
Ethical approval
Citation [2] 5548 0
Link [2] 5548 0
Email [2] 5548 0
Other [2] 5548 0
Summary results
No Results