HealthyEarly Phase 1FIGNCT05986955
The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health
A Early Phase 1 study testing Diet in people with Healthy, run by Monash University at 1 site in Australia.
Trial summary
The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are: what is the the rate of gastrointestinal colonisation of food derived bacteria? what is the contribution of food derived bacteria to gut microbiome… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jun 2023to 28 Nov 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)
- Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome, inflammatory bowel disease or type 1/2 diabetes)
- Do not require drug-therapy (e.g. steroids or insulin or antibiotics)
- Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre supplementation
- Any condition that will affect participation in the study
- Not pregnant, planning a pregnancy or breastfeeding
Show all 10Show fewer
- Able to complete a two-month dietary study and agree to eating all meals provided
- Have no dietary allergies or dietary restrictions that prevent consumption of provided study meals
- Open bowels regularly - mostly daily
- Able to read, write and understand English
Who cannot join
- Dietary concerns identified by dietitian
- Aged less than 18 years and older than 65 years
- Diagnosed with a medical condition that requires drug therapy
- Taking medications or supplements known to alter gastrointestinal microbiota
- Women who are pregnant, planning a pregnancy or breastfeeding
- Anyone with a diagnosed gastrointestinal condition/disease e.g. irritable bowel syndrome or inflammatory bowel disease
Show all 10Show fewer
- Known dietary allergy and/or intolerance, follows a vegan or vegetarian diet, or has coeliac disease
- Anyone with a preference for specific food avoidance or exclusion of certain ingredients in habitual diet
- Unable to tolerate blood collection procedures
- Unable to provide regular stool samples throughout the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Derived Bacteria and Their Role in Treating Disease
The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are:
- what is the the rate of gastrointestinal colonisation of food derived bacteria?
- what is the contribution of food derived bacteria to gut microbiome stability?
Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.
Read the detailed description
To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation.
- Conditions
- Healthy
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Participants will be assigned prospectively to microbial or non-microbial diet for first phase of trial and will then cross over to the alternate diet following a washout period.
| Study group | Role | What they receive |
|---|---|---|
| Specified Diet 1 - Microbial Diet | Experimental | Participants provided with a typical Australian diet including all food groups as described by the Australian Guide to Healthy Eating without any dietary exclusions. Meals have been designed by researchers and dietitians and prepared by professional chefs. Receives: Other: Diet |
| Specified Diet 2 - Non-microbial Diet | Active comparator | Diet provided to participants is identical to Specified Diet 1 however after cooking and packaging, food for this arm will be sterilised by irradiation in line with International Organisation for Standardisation (ISO) standards and Australian code of good manufacturing practice. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of gut microbiome
Sequencing and bacterial culturing of stool samples
Measured: Day 1, 4, 7, 11 and 14 of each phase
Secondary outcomes (16)
Participant body mass index (BMI)
Assessed independently using height and weight measurements and appropriate formula
Measured: BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
Participant standing height
Measured by stadiometer
Measured: Height will be measured on day 14 (at end of each diet phase (fortnightly))
Participant weight
Measured using balance scales
Measured: Weight will be measured on day 14 (at end of each diet phase (fortnightly))
Participant waist circumference
Measured using standard measuring tape
Measured: Baseline day 1 and end of each 14-day diet phase
Participant Hip circumference
Measured using standard measuring tape
Measured: Baseline day 1 and end of each 14-day diet phase
Resting systolic and diastolic blood pressure
Measured using digital blood pressure monitor
Measured: Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
Mental Health Assessment
Perceived Stress Scale survey completed by participants
Measured: Completed at day 1 and end of study (day 56)
Dietary compliance
Measured by participant completed daily diet checklist noting the amount of food they consumed of provided meals during specific diet 1 and 2 phases
Measured: Day 1 to Day 14 of specified diet 1 and diet 2 phases
Habitual dietary intake
Using research food diary mobile phone application
Measured: Daily throughout 14-day baseline habitual and habitual washout phases
Changes in physical activity levels
Using International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Measured: Completed at each of each 14-day diet phase
Glucose levels
Blood samples collected will be assessed for glucose levels
Measured: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Lipid studies
Blood samples collected will be assessed for lipid studies
Measured: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
Completion of Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
Measured: End of each 14-day diet phase
Gastrointestinal symptomatology
Completion of Gastrointestinal Symptom Rating Scale (GSRS)
Measured: Baseline day 1 and day 14 of each diet phase (fortnightly)
Bowel movement
Completion of Bristol Stool Chart questionnaires
Measured: Baseline day 1 and day 14 of each diet phase (fortnightly)
End of study optional semi-structured interview
Interview participants to assess challenges of adhering to study and compliance
Measured: End of study (at least 8 weeks post-randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start16 Jun 2023
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sam Forster, Monash University
- Investigators
- Dr. Sam Forster, Principal investigator, Hudson Institue, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986955
- Sponsor's protocol ID
- RES-21-0000-602A
- Acronym
- FIG
- Status last verified
- Apr 2025
- First submitted
- 19 Jul 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Applications made for reasonable access to de-identified study data will be made on a case-by-case basis by the study team. Data-specified appropriate analysis will be determined when required. Applications for data accessibility will be made on a case-by-case basis by study team.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Derived Bacteria and Their Role in Treating Disease
- ClinicalTrials.gov ID
- NCT05986955
- Acronym / sponsor ID
- FIG / RES-21-0000-602A
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are:
- what is the the rate of gastrointestinal colonisation of food derived bacteria?
- what is the contribution of food derived bacteria to gut microbiome stability?
Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.
Detailed description
To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specified Diet 1 - Microbial Diet | Experimental | Other: DietParticipants provided with a typical Australian diet including all food groups as described by the Australian Guide to Healthy Eating without any dietary exclusions. Meals have been designed by researchers and dietitians and prepared by professional chefs. |
| Specified Diet 2 - Non-microbial Diet | Active comparator | Other: DietDiet provided to participants is identical to Specified Diet 1 however after cooking and packaging, food for this arm will be sterilised by irradiation in line with International Organisation for Standardisation (ISO) standards and Australian code of good manufacturing practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)
- Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome, inflammatory bowel disease or type 1/2 diabetes)
- Do not require drug-therapy (e.g. steroids or insulin or antibiotics)
- Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre supplementation
- Any condition that will affect participation in the study
Key exclusion criteria (10 listed)
- Dietary concerns identified by dietitian
- Aged less than 18 years and older than 65 years
- Diagnosed with a medical condition that requires drug therapy
- Taking medications or supplements known to alter gastrointestinal microbiota
- Women who are pregnant, planning a pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietParticipants will be assigned prospectively to microbial or non-microbial diet for first phase of trial and will then cross over to the alternate diet following a washout period. | Other | Specified Diet 1 - Microbial Diet, Specified Diet 2 - Non-microbial Diet |
Primary outcome
Characterisation of gut microbiome
Time frame: Day 1, 4, 7, 11 and 14 of each phase
Sequencing and bacterial culturing of stool samples
16 secondary outcomes
Participant body mass index (BMI)
Time frame: BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
Participant standing height
Time frame: Height will be measured on day 14 (at end of each diet phase (fortnightly))
Participant weight
Time frame: Weight will be measured on day 14 (at end of each diet phase (fortnightly))
Participant waist circumference
Time frame: Baseline day 1 and end of each 14-day diet phase
Participant Hip circumference
Time frame: Baseline day 1 and end of each 14-day diet phase
Resting systolic and diastolic blood pressure
Time frame: Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly))
Mental Health Assessment
Time frame: Completed at day 1 and end of study (day 56)
Dietary compliance
Time frame: Day 1 to Day 14 of specified diet 1 and diet 2 phases
Habitual dietary intake
Time frame: Daily throughout 14-day baseline habitual and habitual washout phases
Changes in physical activity levels
Time frame: Completed at each of each 14-day diet phase
Glucose levels
Time frame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Lipid studies
Time frame: Blood collected at baseline day 1 and day 14 of each phase (fortnightly)
Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
Time frame: End of each 14-day diet phase
Gastrointestinal symptomatology
Time frame: Baseline day 1 and day 14 of each diet phase (fortnightly)
Bowel movement
Time frame: Baseline day 1 and day 14 of each diet phase (fortnightly)
End of study optional semi-structured interview
Time frame: End of study (at least 8 weeks post-randomisation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. Applications made for reasonable access to de-identified study data will be made on a case-by-case basis by the study team. Data-specified appropriate analysis will be determined when required. Applications for data accessibility will be made on a case-by-case basis by study team.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sam Forster principal investigator
Hudson Institue, Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diet in people with Healthy, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of gut microbiome (time frame: Day 1, 4, 7, 11 and 14 of each phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.