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Examining the effects of probiotics on the immune system.

Examining the effects of probiotics on the immune system in healthy adults.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000611325
Acronym
ProImmune
Enrollment
120
Registered
2017-04-28
Start date
2017-02-22
Completion date
2017-06-06
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to examine the effects of probiotics on immune system function. 120 healthy adults will take part and we will investigate the immune effects of six commercially available probiotics (20 participants in each probiotic group). Participants will take a probiotic for 2 weeks and provide a blood sample on Day 1, Day 8 and Day 15 (the day after their last probiotic dose). We will examine immune system function using the three blood samples provided. This study will provide important information on whether taking probiotics improves the function of the immune system.

Interventions

Name of intervention, dose and duration: The effect of probiotics on immune regulatory function, Six commercially available probiotics will be examined (one probiotic per study group): Eczema shield (Ethical Nutrients) – 2 capsules per day (2x10^10 cfu/day, Lactobacillus rhamnosus) for 14 days Travel bug (Ethical Nutrients) – 2 capsules per day (1 x 10^10 cfu/day, Saccharomyces boulardii) for 14 days Mutaflor (Natural Therapy Imports) - 2 capsules twice a day (1 x 10^10 cfu twice a day, E. coli

Name of intervention, dose and duration: The effect of probiotics on immune regulatory function, Six commercially available probiotics will be examined (one probiotic per study group): Eczema shield (Ethical Nutrients) – 2 capsules per day (2x10^10 cfu/day, Lactobacillus rhamnosus) for 14 days Travel bug (Ethical Nutrients) – 2 capsules per day (1 x 10^10 cfu/day, Saccharomyces boulardii) for 14 days Mutaflor (Natural Therapy Imports) - 2 capsules twice a day (1 x 10^10 cfu twice a day, E. coli Nissle 1917 ) for 14 days Bifidobacteria lactis – 2 capsules per day (1 x 10^10 cfu/day) for 14 days Streptococcus thermophilus – dry powder 100 billion cfu per g (2 x 10^10 cfu per day, i.e. 200mg per day) for 14 days Bifidobacteria breve – dry powder 100 billion cfu per g (2 x 10^10 cfu per day, i.e. 200mg per day) for 14 days Mode of adminstration: Oral Personalised intervention: No Intervention adherence: Compliance will be monitored by capsule counts and by completion of a daily diary of doses taken. Diaries will be reviewed at Day 8 and Day 15 and missed doses recorded. Non-compliance will be defined as missing more than 1 dose. The study nurse will assess compliance.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy adults aged between 18-60 years.

Exclusion criteria

* Already taking probiotics * Inflammatory intestinal conditions, indwelling catheter, gastrostomy, or other condition associated with increased risk of probiotic associated sepsis * Proven or suspected immunodeficiency * Pregnancy * Recent intake of antibiotics in the preceding 1 week

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026