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Effects of Bifidobacterium animalis Subsp. lactis (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.

ABSTRACT: Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by a wide range of clinical manifestations, including obesity, hyperphagia, and behavioral problems. Bifidobacterium animalis subsp. lactis strain BPL1 has been shown to improve central adiposity in adults with simple obesity. To evaluate BPL1's effects in children with PWS, we performed a randomized crossover trial among 39 patients (mean age 10.4 years). Participants were randomized to placebo-BPL1 (n = 19) or BPL1-placebo (n = 20) sequences and underwent a 12-week period with placebo/BPL1 treatments, a 12-week washout period, and a 12-week period with the crossover treatment. Thirty-five subjects completed the study. The main outcome was changes in adiposity, measured by dual-energy X-ray absorptiometry. Secondary outcomes included lipid and glucose metabolism, hyperphagia, and mental health symptoms. Generalized linear modeling was applied to assess differences between treatments. While BPL1 did not modify total fat mass compared to placebo, BPL1 decreased abdominal adiposity in a subgroup of patients older than 4.5 years (n = 28). BPL1 improved fasting insulin concentration and insulin sensitivity. Furthermore, we observed modest improvements in some mental health symptoms. A follow-up trial with a longer treatment period is warranted to determine whether BPL1 supplementation can provide a long-term therapeutic approach for children with PWS (ClinicalTrials.gov NCT03548480).

SUBMITTER: Amat-Bou M

PROVIDER: S-EPMC7650793 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effects of Bifidobacterium animalis Subsp. lactis (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.

Amat-Bou Montse M Garcia-Ribera Sonika S Climent Eric E Piquer-Garcia Irene I Corripio Raquel R Sanchez-Infantes David D Villalta Laia L Elias Maria M Jiménez-Chillarón Josep C JC Chenoll Empar E Ramón Daniel D Ibañez Lourdes L Ramon-Krauel Marta M Lerin Carles C

Nutrients 20201013 10

Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by a wide range of clinical manifestations, including obesity, hyperphagia, and behavioral problems. Bifidobacterium animalis subsp. lactis strain BPL1 has been shown to improve central adiposity in adults with simple obesity. To evaluate BPL1's effects in children with PWS, we performed a randomized crossover trial among 39 patients (mean age 10.4 years). Participants were randomized to placebo-BPL1 (n = 1 ...[more]

PMID: 33066107

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Project description:To evaluate the influence of oral probiotic Bifidobacterium animalis subsp. lactis (BL-11) supplementation on salivary microbiota composition and the association with growth parameters, and behavioral symptoms in individuals with Prader-Willi syndrome (PWS). In this post hoc analysis, we included a subset of 36 PWS patients with available saliva samples from our original randomized, double-blinded, placebo-controlled trial (Chinese Clinical Trial Registry, ChiCTR1900022646, April 20, 2019). Among the 36 subjects, 17 subjects were allocated to the probiotic group for daily use of the BL-11 probiotic and 19 subjects were allocated to the placebo group. Groupwise and longitudinal differences in salivary microbiota abundances, biodiversity metrics, and height were analyzed. Linear correlations were found between identified differentially abundant salivary microbiota and clinical parameters. Salivary microbiome α-diversity was found to be higher in the probiotic-treated group at week 12 relative to placebo controls (P < 0.05). Leptotrichia, Paracoccus, and Faecalibacterium were found to be more abundant in the probiotic-treated group (P < 0.05). Salivary microbiota abundance and predicted functional profiling abundance correlations were found to be associated with anti-inflammation, anti-obesity, toxin degradation, and anti-oxidative injury effects (Q < 0.1). Several oral taxa also displayed correlations with social behavior severity scores in the probiotic-treated group (Q < 0.1). The findings suggest novel salivary microbiota compositional changes in response to the oral supplementation of BL-11 probiotic in individuals with PWS. The observed differentially abundant taxa between groups post-treatment were highly correlated with interventional effects on growth and social behaviors, although further investigation is warranted. Clinical Trial Registration The original clinical trial was registered under the Chinese Clinical Trial Registry with registration number ChiCTR1900022646 (April 20, 2019).

Project description:Commercial probiotic bacteria must be tested for acquired antibiotic resistance elements to avoid potential transfer to pathogens. The European Food Safety Authority recommends testing resistance using microdilution culture techniques previously used to establish inhibitory thresholds for the Bifidobacterium genus. Many Bifidobacterium animalis subsp. lactis strains exhibit increased resistance to tetracycline, historically attributed to the ribosomal protection gene tet(W). However, some strains that harbor genetically identical tet(W) genes show various inhibition levels, suggesting that other genetic elements also contribute to observed differences. Here, we adapted several molecular assays to confirm the inhibition of B. animalis subsp. lactis strains Bl-04 and HN019 and employed RNA sequencing to assess the transcriptional differences related to genomic polymorphisms. We detected specific stress responses to the antibiotic by correlating ATP concentration to number of viable genome copies from droplet digital PCR and found that the bacteria were still metabolically active in high drug concentrations. Transcriptional analyses revealed that several polymorphic regions, particularly a novel multidrug efflux transporter, were differentially expressed between the strains in each experimental condition, likely having phenotypic effects. We also found that the tet(W) gene was upregulated only during subinhibitory tetracycline concentrations, while two novel tetracycline resistance genes were upregulated at high concentrations. Furthermore, many genes involved in amino acid metabolism and transporter function were upregulated, while genes for complex carbohydrate utilization, protein metabolism, and clustered regularly interspaced short palindromic repeat(s) (CRISPR)-Cas systems were downregulated. These results provide high-throughput means for assessing antibiotic resistances of two highly related probiotic strains and determine the genetic network that contributes to the global tetracycline response.IMPORTANCEBifidobacterium animalis subsp. lactis is widely used in human food and dietary supplements. Although well documented to be safe, B. animalis subsp. lactis strains must not contain transferable antibiotic resistance elements. Many B. animalis subsp. lactis strains have different resistance measurements despite being genetically similar, and the reasons for this are not well understood. In the current study, we sought to examine how genomic differences between two closely related industrial B. animalis subsp. lactis strains contribute to different resistance levels. This will lead to a better understanding of resistance, identify future targets for analysis of transferability, and expand our understanding of tetracycline resistance in bacteria.

Dataset Information

Effects of Bifidobacterium animalis Subsp. lactis (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.

Publications

Effects of <i>Bifidobacterium animalis</i> Subsp. <i>lactis</i> (BPL1) Supplementation in Children and Adolescents with Prader-Willi Syndrome: A Randomized Crossover Trial.

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