Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study

Weizman, Zvi; Alsheikh, Ahmed

doi:10.1080/07315724.2006.10719554

Cited by 79 publications

(71 citation statements)

References 21 publications

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“…In reports focusing on safety, AE were not attributable to the supplemented organisms in infants administered Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. lactis HN019 (12), combinations of Bifidobacterium longum BL999, Lactobacillus rhamnosus LPR and Lactobacillus paracasei ST11 (13), and Bifidobacterium lactis BB-12 and Lactobacillus reuteri ATCC 55730 (14). Similarly, adverse outcomes have not been associated with infant formula milks containing 1 or more bacterial species with a prebiotic; organisms have included Bifidobacterium longum BL999 (15), Lactobacillus rhamnosus GG and LC705, Bifidobacterium breve Bb99 and Propionibacterium freudenreichii spp.…”

Section: Discussionmentioning

confidence: 97%

Dietary Supplementation with Lactobacilli and Bifidobacteria Is Well Tolerated and Not Associated with Adverse Events during Late Pregnancy and Early Infancy

Allen

Jordan

Storey

et al. 2010

The Journal of Nutrition

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Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe use, it is important to identify any adverse effects in potentially vulnerable populations. In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 x 10(10) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0-6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires. Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers' assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention. Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.

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Section: Discussionmentioning

confidence: 97%

Dietary Supplementation with Lactobacilli and Bifidobacteria Is Well Tolerated and Not Associated with Adverse Events during Late Pregnancy and Early Infancy

Allen

Jordan

Storey

et al. 2010

The Journal of Nutrition

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“…Despite studies suggesting that probiotics are well tolerated and safe [17,18] , the regulatory environments in Europe and the United States are vague with respect to the potential health benefits of probiotics in infant formula [19] . This is especially important for healthcare professionals who advise mothers on how to proceed once the decision not to breastfeed has been made.…”

Section: Introductionmentioning

confidence: 99%

The Effect of <i>Bifidobacterium lactis</i> on the Growth of Infants: A Pooled Analysis of Randomized Controlled Studies

2009

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Background/Aims: Breast milk is the best source of nutrition for the growth of the newborn infant. It is therefore essential that mothers who cannot breastfeed or choose not to are provided with alternatives that closely match the composition and functionality of breast milk. This study aimed to investigate the growth effects of probiotic-supplemented formulas on both healthy and vulnerable populations of infants. Methods: A meta-analysis of data from 5 randomized controlled clinical trials that included infants fed formulas containing a probiotic Bifidobacterium lactis CNCM I-3446 was performed (n = 525). A sub-analysis was performed among infants of HIV-positive mothers (n = 120). Growth measurements (gain in weight and body mass index, BMI, from enrollment to 120 days) were compared between infants fed a formula containing B. lactis and those fed a control formula. Changes in length and Z-scores were also compared. Results: Formula with B.lactis was demonstrated to be at least as good as formula without B. lactis in the meta-analysis of 5 studies. The lower boundary of the 95% confidence interval (CI) of the differences in mean weight gain (95% CI 0.09–2.93 g/day) was above the predefined non-inferiority margin of –3.0 g/day. Moreover, among infants with HIV-positive mothers, weight gain of those taking B. lactis was significantly higher than of those not taking B. lactis, by 3.1 g/day (95% CI 0.4–5.8 g/day, p = 0.0226) and the BMI gains were significantly higher, by 6.4 g/m²/day (95% CI 0.0.3–12.5 g/m²/day, p = 0.0400). The corresponding weight for age and BMI Z-scores were also significantly higher, by 0.37 (95% CI 0.03–0.71, p = 0.0308) and by 0.42 (95% CI 0.02–0.83, p = 0.0377), respectively, whereas differences in length gain or length-for-age Z-score were not significant. Among infants in the non-HIV mothers group, there were no significant differences between infants fed formulas with or without B. lactis, for any of the growth parameters. Conclusions: The analysis suggests that B. lactis may have a positive effect on growth in vulnerable populations, specifically in infants born to mothers with HIV.

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“…An increasing number of studies, including ours have shown that certain strains of lactobacilli administered orally around the time of vaccination have similar effects in enhancing humoral and/or cellular immune responses to mucosal as well as parenteral vaccines as conventional adjuvants [15, 17, 20, 21, 25, 47]. Yet, probiotics are safe, even for newborn infants and the elderly [21, 48]; therefore their use will not raise concerns for side effects as for any newly introduced conventional adjuvants. The use of probiotics as adjuvants (with the appropriate strain and optimal dosage) is a promising practical novel approach to enhance vaccine immunogenicity and protective efficacy.…”

Section: Discussionmentioning

confidence: 99%

High dose and low dose Lactobacillus acidophilus exerted differential immune modulating effects on T cell immune responses induced by an oral human rotavirus vaccine in gnotobiotic pigs

Wen

Bui

et al. 2012

Vaccine

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Background Strain-specific effects of probiotics in pro- or anti-inflammatory immune responses have been well recognized. Several proinflammatory Lactobacillus strains have been shown to act as adjuvants to enhance the immunogenicity of vaccines. However, dose effects of probiotics in modulating immune responses are not clearly understood. This study examined the dose effects of Lactobacillus acidophilus (LA) NCFM strain on T cell immune responses to rotavirus vaccination in a gnotobiotic (Gn) pig model. Methods Frequencies of IFN-γ producing CD4+ and CD8+ T cell and IL-10 and TGF-β producing CD4+CD25+ and CD4+CD25- regulatory T (Treg) cell responses were determined in the intestinal and systemic lymphoid tissues of Gn pigs vaccinated with an oral human rotavirus vaccine in conjunction with low dose (5 feedings; up to 106 colony forming units [CFU]/dose) or high dose (14 feedings; up to 109 CFU/dose) or without LA feeding. Results Low dose LA significantly promoted IFN-γ producing T cell responses and down-regulated Treg cell responses and their TGF-β and IL-10 productions in all the tissues compared to the high dose LA and control groups. To the contrary, high dose LA increased the frequencies of Treg cells in most of the tissues compared to the control groups. The dose effects of LA on IFN-γ producing T cell and CD4+CD25- Treg cell immune responses were similar in the intestinal and systemic lymphoid tissues and were independent from the vaccination. Conclusion Thus the same probiotic strain in different doses can either promote or suppress IFN-γ producing T cell or Treg cell immune responses. These findings have significant implications in the use of probiotic lactobacilli as immunostimulatory versus immunoregulatory agents. Probiotics can be ineffective or even detrimental if not used at the optimal dosage for the appropriate purposes.

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Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study

Abstract: The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy, was safe, well tolerated and did not adversely affect growth, stooling habits or infant behavior.

Cited by 79 publications

References 21 publications

Dietary Supplementation with Lactobacilli and Bifidobacteria Is Well Tolerated and Not Associated with Adverse Events during Late Pregnancy and Early Infancy

Dietary Supplementation with Lactobacilli and Bifidobacteria Is Well Tolerated and Not Associated with Adverse Events during Late Pregnancy and Early Infancy

The Effect of <i>Bifidobacterium lactis</i> on the Growth of Infants: A Pooled Analysis of Randomized Controlled Studies

High dose and low dose Lactobacillus acidophilus exerted differential immune modulating effects on T cell immune responses induced by an oral human rotavirus vaccine in gnotobiotic pigs

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