Evaluation of the efficacy of probiotic supplements on illness and immunity in healthy active individuals

Randomized placebo-controlled clinical trial assessing the effect of two probiotic supplements on upper respiratory tract and gastrointestinal illness during a winter period in healthy physically active adult subjects.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000130965

Enrollment

450

Registered

2011-02-04

Start date

2010-03-29

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

There is increasing interest in the use of nutritional supplements to improve health and wellbeing. Probiotics are proposed to boost immunity and reduce susceptibility to infection. Common infections, such as URTI, are a significant burden on the community. There is growing body of evidence that probiotic supplementation may reduce the prevalence of URTI and GI illness in the general population. Hypothesis: That a probiotic supplement will enhance immunity and ameliorate the heightened susceptibility to upper respiratory tract illness (URTI) and gastrointestinal tract illness in active well-trained community individuals.

Interventions

Probiotic 1: Lactobacillus spp. and Bifidobacterium spp. at total of 1x10E10 (50:50) per 1g sacchet taken daily mixed into 20-50ml of non-alcoholic beverage during 5 winter months Probiotic 2: Bifidobacterium spp. at 2x10E10 taken daily per 1g sacchet taken daily mixed into 20-50ml of non-alcoholic beverage during 5 winter months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Inclusion to the study will be determined according to physical activity levels with subjects required to be undertaking 3 exercise sessions weekly and a questionnaire to determine subject’s health in the previous month

Exclusion criteria

All participants will be required to declare their use of dietary and/or ergogenic aids that may influence underlying immune function and/or exercise performance. All participants on immuno-modulatory medications will be excluded, including those on steroid based anti-asthma treatments. Subjects who have been on antibiotic treatments in the previous month will also be excluded. A daily illness log will be used to monitor training, health status, diet, use of supplements and other therapeutic agents. Subjects with any symptoms of gastrointestinal disease, such as Crohn’s disease, coelic disease and so on will also be excluded.

Outcome results