Effects of probiotic supplementation over 5 months on routine haematology and clinical chemistry measures in healthy active adults.

2014-07-23
European journal of clinical nutrition 68(11)
- A J Cox
- N P West
- P L Horn
- M J Lehtinen
- G Koerbin
- D B Pyne
- S J Lahtinen
- P A Fricker
- A W Cripps

PubMed: 25052229
DOI: 10.1038/ejcn.2014.137

Study Design

Type: Randomized Controlled Trial (RCT)
Population: healthy active adults
Methods: 150 days of supplementation with either a single- (Bifidobacterium animalis subsp. lactis Bl-04) or a double-strain (Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07) probiotic
Blinding: Double-blind
Duration: 150 days

Rigorous Journal

Use of probiotic-containing foods and probiotic supplements is increasing; however, few studies document safety and tolerability in conjunction with defined clinical end points. This paper reports the effects of 150 days of supplementation with either a single- (Bifidobacterium animalis subsp. lactis Bl-04) or a double-strain (Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07) probiotic on routine haematology and clinical chemistry measures in healthy active adults. Pre- to post-intervention changes in laboratory measures were determined and compared between supplement and placebo groups. Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention. Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges. These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.

Research Insights

Bifidobacterium animalis subsp. lactis Bi-07→Altered Hematology Profile
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Bifidobacterium animalis subsp. lactis Bi-07→Changed Clinical Chemistry Measure
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Bifidobacterium animalis subsp. lactis Bi-07→Reduced Plasma Urea Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated
Bifidobacterium animalis subsp. lactis Bi-07→Reduced Serum Calcium Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated
Bifidobacterium lactis Bl-04→Altered Hematology Profile
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Bifidobacterium lactis Bl-04→Changed Clinical Chemistry Measure
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Bifidobacterium lactis Bl-04→Reduced Plasma Urea Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated
Bifidobacterium lactis Bl-04→Reduced Serum Calcium Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated
Lactobacillus acidophilus NCFM→Altered Hematology Profile
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Lactobacillus acidophilus NCFM→Changed Clinical Chemistry Measure
Overall there were few differences in routine haematology and clinical chemistry measures between supplement and placebo groups post-intervention.
Effect
Neutral
Effect size
Small
Dose
not stated
Lactobacillus acidophilus NCFM→Reduced Plasma Urea Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated
Lactobacillus acidophilus NCFM→Reduced Serum Calcium Level
Exceptions included plasma calcium (P=0.03) and urea (P=0.015); however, observed changes were small and within assay-specific laboratory reference ranges.
Effect
Beneficial
Effect size
Small
Dose
not stated

Adverse Events Reported

Bifidobacterium lactis Bl-04→Overall tolerability
These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.
Finding
Reported
Lactobacillus acidophilus NCFM→Overall tolerability
These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.
Finding
Reported
Bifidobacterium animalis subsp. lactis Bi-07→Overall tolerability
These data provide evidence supporting the use of these probiotic supplements over a period of 5 months in healthy active adults without obvious safety or tolerability issues.
Finding
Reported