Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial

Nocerino, Rita; Paparo, Lorella; Terrin, Gianluca; Pezzella, Vincenza; Amoroso, Antonio; Cosenza, Linda; Cecere, Gaetano; Marco, G. De; Micillo, Maria; Albano, Fabio; Nugnes, Rosa; Ferri, Pasqualina; Ciccarelli, Giuseppe; Giaccio, Giuliana; Spadaro, Raffaella; Maddalena, Ylenia; Canani, Francesco Berni; Canani, R. Berni

doi:10.1016/j.clnu.2015.12.004

Cited by 98 publications

(121 citation statements)

References 28 publications

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“…Human beta‐defensin 2, LL‐37 and sIgA were measured from the supernatants of faecal homogenates, using commercial kits as previously described . HBD‐2 was measured using a HBD‐2 (Human) ELISA kit (Phoenix Pharmaceuticals, Inc), LL‐37 using an ELISA human kit (Hycult biotechnology) and sIgA using indirect enzyme immunoassay (Salimetrics LLC).…”

Section: Methodsmentioning

confidence: 99%

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial

Nocerino

Filippis

Cecere

et al. 2019

Aliment Pharmacol Ther

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Summary Background The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics. Aims To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB‐12® (BB‐12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency. Methods Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB‐12 (1 × 109 CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta‐defensin‐2 (HBD‐2), cathelicidin (LL‐37), secretory IgA (sIgA) and faecal calprotectin levels were assessed. Results Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB‐12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB‐12 group (−4.7 ± 3.4 vs −2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB‐12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD‐2, LL‐37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB‐12 group. Conclusions Supplementation with BB‐12 is effective in managing infant colic. The effect could derive from immune and non‐immune mechanisms associated with a modulation of gut microbiota structure and function.

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Section: Methodsmentioning

confidence: 99%

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial

Nocerino

Filippis

Cecere

et al. 2019

Aliment Pharmacol Ther

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“…), reduction of infectious disease among children by fermented rice or milk (Nocerino et al . ) and short‐term improvements in bone health markers in osteoporosis patients by kefir (Tu et al . ).…”

Section: Fermented Foods: Another Source Of Probiotics?mentioning

confidence: 99%

“…Still, even if fermentation-associated microbes are just passing through, there is emerging evidence that they can nonetheless influence the normal microbiota, communicate with the host immune system and exert other positive effects (reviewed in Marco et al 2017). Outcomes of recent clinical trials include improvements in blood pressure in hypertensive adults by fermented milk (Beltran-Barrientos et al 2018), reduction of infectious disease among children by fermented rice or milk (Nocerino et al 2017) and short-term improvements in bone health markers in osteoporosis patients by kefir (Tu et al 2015).…”

Section: Characteristics Of Probioticsmentioning

confidence: 99%

Probiotics for human use

Sanders¹,

et al. 2018

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Probiotics have become a popular approach for managing digestive and immune health and are being recommended more frequently as effective therapeutic interventions by medical professionals. Introduced early in the 20th century, the science of probiotics has advanced considerably, especially in the past two decades. Researchers have adopted a consensus definition, begun to understand many of the mechanisms of action, defined characteristics important to probiotic function and have obtained clinical evidence supporting probiotic health benefits and product quality. Nonetheless, a need remains for clear, evidence‐based communications to consumers on the role of probiotics in a healthy diet and to healthcare providers regarding clinical use. However, regulatory frameworks in many countries have restricted progress on this front. There is a need for additional research to further clarify the most effective probiotics for given health outcomes and to identify people most likely to respond to specific probiotic interventions. This review provides current perspective on the probiotic concept, discusses evidence‐based probiotic interventions, considers fermented foods with regard to probiotics and addresses some regulatory challenges facing the probiotic field.

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“…The Panel concluded that Nocerino et al (2017) showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The Panel concluded that Nocerino et al (2017) showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT.…”

Section: Human Intervention Studiesmentioning

confidence: 99%

“…The Panel concluded that Nocerino et al (2017) showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The Panel also noted that this study shared the same inconsistencies in the reporting of the process and criteria used for the diagnosis of URTI as identified for the study by Nocerino et al (2017). In relation to the second study (Corsello et al, 2017), the Panel noted that the vast majority of the participants were recruited in one centre (i.e.…”

Section: Human Intervention Studiesmentioning

confidence: 99%

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Turck¹,

Castenmiller²,

Henauw³

et al. 2019

EFS2

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Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respiratory tract (URT). The food Nutrimune (a pasteurised cow's skim milk fermented with Lactobacillus paracasei CBA L74) which is the subject of the health claim is sufficiently characterised. The Panel considers that immune defence against pathogens in GI tract and URT is a beneficial physiological effect. Two human intervention studies were submitted as being pertinent to the claim, which were evaluated by the Panel in the previous application. One human intervention study from which conclusions could be drawn showed an effect of Nutrimune on immune defence against pathogens in the GI tract and the URT. The post hoc re-analysis of the two human studies combined does not address the methodological limitations of the second study raised in the previous opinion, i.e. that the study was not planned, designed, randomised and analysed as a multicentre study, and that the large disparity of subjects in the three centres was not duly justified. The results from one animal study could support an effect of Nutrimune on defence against pathogens in the GI tract. No evidence was provided for a plausible mechanism by which Nutrimune could exert the claimed effect in vivo in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Nutrimune and immune defence against pathogens in the GI tract and URT.

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Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial

Cited by 98 publications

References 28 publications

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial

Probiotics for human use

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

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Cow's milk and rice fermented with Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial

Cited by 98 publications

References 28 publications

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12® in infant colic: A randomised, double blind, placebo‐controlled trial

Probiotics for human use

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

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Product

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The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial

The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB‐12^® in infant colic: A randomised, double blind, placebo‐controlled trial