Nicholas P West1, Peggy L Horn2, David B Pyne3, Val J Gebski4, Sampo J Lahtinen5, Peter A Fricker6, Allan W Cripps7. 1. Griffith Health Institute, Griffith University, QLD 4215, Australia. 2. Physiology, Australian Institute of Sport, Canberra, ACT 2617, Australia. 3. Griffith Health Institute, Griffith University, QLD 4215, Australia; Physiology, Australian Institute of Sport, Canberra, ACT 2617, Australia; Medical School, Australian National University, Canberra, ACT 2600, Australia. 4. NHMRC Clinical Trials Centre, University of Sydney, NSW 1450, Australia. 5. DuPont Nutrition & Health, Danisco Sweeteners Oy, Health & Nutrition, Sokeritehtaantie 20, 02460 Kantvik, Finland. 6. Australian Institute of Sport, Canberra, ACT 2617, Australia. 7. Griffith Health Institute, Griffith University, QLD 4215, Australia. Electronic address: allan.cripps@griffith.edu.au.
Abstract
BACKGROUND & AIMS: To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women. METHODS: A randomised double-blind placebo-controlled trial was conducted. Four hundred and sixty five participants (241 males; age 35 ±12 y (mean ± SD) and 224 females; age 36 ± 12 y) were assigned to one of three groups: Group 1 - Bifidobacterium animalis subsp. lactis Bl-04 (Bl-04) 2.0 × 10(9)colony forming units per day, CFU per day, Group 2 - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07 (NCFM & Bi-07) 5 × 10(9) CFU each per day) or Group 3 - placebo mixed in a drink. RESULTS: The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group (hazard ratio 0.73; 95% confidence interval 0.55-0.95; P = 0.022) compared to placebo. There was no significant difference in illness risk between the NCFM & Bi-07 group (hazard ratio 0.81; 0.62-1.08; P = 0.15) and the placebo group. There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo (placebo 2.5 months; Bl-04 3.2 months; NCFM & Bi-07 3.4 months). There were insufficient GI illness episodes for analysis. The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity (8.5%; 6.7%-10%; P < 0.003) than the placebo group. CONCLUSION: The probiotic Bl-04 appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry: Number ACTRN12611000130965.
RCT Entities:
BACKGROUND & AIMS: To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women. METHODS: A randomised double-blind placebo-controlled trial was conducted. Four hundred and sixty five participants (241 males; age 35 ± 12 y (mean ± SD) and 224 females; age 36 ± 12 y) were assigned to one of three groups: Group 1 - Bifidobacterium animalis subsp. lactis Bl-04 (Bl-04) 2.0 × 10(9)colony forming units per day, CFU per day, Group 2 - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07 (NCFM & Bi-07) 5 × 10(9) CFU each per day) or Group 3 - placebo mixed in a drink. RESULTS: The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group (hazard ratio 0.73; 95% confidence interval 0.55-0.95; P = 0.022) compared to placebo. There was no significant difference in illness risk between the NCFM & Bi-07 group (hazard ratio 0.81; 0.62-1.08; P = 0.15) and the placebo group. There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo (placebo 2.5 months; Bl-04 3.2 months; NCFM & Bi-07 3.4 months). There were insufficient GI illness episodes for analysis. The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity (8.5%; 6.7%-10%; P < 0.003) than the placebo group. CONCLUSION: The probiotic Bl-04 appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry: Number ACTRN12611000130965.
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