The Impact of Food on Gut Microbiome Composition - a Clinical Trial Determining the Influence of Diet in Gut Microbiome Colonisation and Host Health (FIG)

April 21, 2025 updated by: Dr. Sam Forster, Monash University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Notting Hill, Victoria, Australia, 3168
        • BASE Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Specified Diet 1 - Microbial Diet
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.
Other: Diet
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.
Active Comparator: Specified Diet 2 - Non-microbial Diet
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.
Other: Diet
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Characterisation of gut microbiome
Time Frame: Day 1, 4, 7, 11 and 14 of each phase
Sequencing and bacterial culturing of stool samples
Day 1, 4, 7, 11 and 14 of each phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant body mass index (BMI)
Time Frame: BMI will be calculated on day 14 (at end of each diet phase (fortnightly))
Assessed independently using height and weight measurements and appropriate formula
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))
Measured by stadiometer
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))
Measured using balance scales
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
Measured using standard measuring tape
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
Measured using standard measuring tape
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))
Measured using digital blood pressure monitor
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)
Perceived Stress Scale survey completed by participants
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
Measured by participant completed daily diet checklist noting the amount of food they consumed of provided meals during specific diet 1 and 2 phases
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
Using research food diary mobile phone application
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
Using International Physical Activity Questionnaire - Short Form (IPAQ-SF)
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)
Blood samples collected will be assessed for glucose levels
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)
Blood samples collected will be assessed for lipid studies
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
Completion of Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)
End of each 14-day diet phase
Gastrointestinal symptomatology
Time Frame: Baseline day 1 and day 14 of each diet phase (fortnightly)
Completion of Gastrointestinal Symptom Rating Scale (GSRS)
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)
Completion of Bristol Stool Chart questionnaires
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)
Interview participants to assess challenges of adhering to study and compliance
End of study (at least 8 weeks post-randomisation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Monash University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Sam Forster, Hudson Institue, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RES-21-0000-602A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Accessibility to individual participant data (IPD) and supporting information will be determined at a later date and on a case-by-case basis

IPD Sharing Access Criteria

Accessibility will be assessed on a case-by-case basis

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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