None listed
Conditions
Brief summary
The human gut microbiome plays a pivotal role in maintaining gastrointestinal health, immune function, and has been associated with the development and progression of various chronic illnesses. There remains an unmet need for probiotics that provide clinically validated, reproducible, and lasting benefits in broader contexts such as disease prevention and health promotion. In our research, we have developed a bank of isolated microbial strains derived from healthy FMT donors and supported by findings from prior FMT clinical trials conducted by our group and others. These strains have demonstrated consistent clinical and microbiological effects and are being investigated as candidates for a next-generation probiotic formulation. We are examining the impact of administering a combination of these organisms as a probiotic in healthy individuals to assess effects on the gut microbiome.
Interventions
The probiotic will be a combination of novel strains collectively referred to MTC01. There are 3 planned phases where an individual participant will receive only one group of strains with the composition to be determined based on the microbial analyses in the preceding phase. Only the first phase has been defined at this point in time.
The first phases will have intermittent dosing face to face with the study coordinators at Day 0, 3 and 7 where capsules will be administered to achieve a dose
The probiotic will be a combination of novel strains collectively referred to MTC01. There are 3 planned phases where an individual participant will receive only one group of strains with the composition to be determined based on the microbial analyses in the preceding phase. Only the first phase has been defined at this point in time. The first phases will have intermittent dosing face to face with the study coordinators at Day 0, 3 and 7 where capsules will be administered to achieve a dose of 5-6x109 in 15 or fewer capsules. In each phase there will be 2 groups, 1 receiving high and low dose therapy. Low dose subjects will receive capsules formulated to achieve a dose of 5x109 (2x108 – 5x109) in 15 or fewer capsules, while high dose subjects will receive a dose of 2.6x1011 (1x1010 – 5x1011) in 15 or fewer capsules
Sponsors
University of New South Wales
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged >18 • Healthy participants • Able to provide informed consent + willing to collect required samples during the study period. • Ability to attend in-person visits during the trial period • Ability to appropriately store investigative product in a freezer
Exclusion criteria
• Any concurrent medical conditions, including but not limited to o IBD/IBS, Cancer, Metabolic syndrome, • Antibiotics or probiotics within 4 weeks of enrolment • Patients unable to give informed consent • Currently pregnant or planning for pregnancy within the next 6 months.
Outcome results
None listed