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Randomized Controlled Trial
. 2020 Oct 13;12(10):3123.
doi: 10.3390/nu12103123.

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

Montse Amat-Bou  1   2 , Sonika Garcia-Ribera  1   2 , Eric Climent  3 , Irene Piquer-Garcia  4 , Raquel Corripio  5 , David Sanchez-Infantes  4   6 , Laia Villalta  1   7 , Maria Elias  1   7 , Josep C Jiménez-Chillarón  1   2 , Empar Chenoll  3 , Daniel Ramón  3 , Lourdes Ibañez  1   2   8 , Marta Ramon-Krauel  1   2 , Carles Lerin  1   2
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Randomized Controlled Trial

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

Montse Amat-Bou et al. Nutrients. .

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).

Keywords: Prader–Willi syndrome; gut microbiota; hyperphagia; insulin sensitivity; mental health; obesity; probiotic supplementation.

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Conflict of interest statement

Eric Climent (E.C.), Empar Chenoll (E.C.), and Daniel Ramón (D.R.) are employees of Archer Daniels Midland Co-Biopolis (Valencia, Spain). The rest of the authors declare no conflict of interests. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flow chart of the study participants. The flow chart of participants throughout the study is shown. A corresponds to placebo treatment and B to Bifidobacterium animalis subsp. lactis strain BPL1 probiotic treatment. AB, treatment sequence placebo-BPL1; BA, treatment sequence BPL1-placebo.
Figure 2
Figure 2
Changes in abundance of species during placebo and BPL1 treatment periods. Violin charts show log2 fold changes during placebo (white) and probiotic (grey) periods. Horizontal bars correspond to median values of log2 fold change. p values are from paired Wilcoxon signed-rank test between placebo and probiotic groups.
See this image and copyright information in PMC

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