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

  • 2020-10-13
  • Nutrients 12(10)
    • Montse Amat-Bou
    • Sonika Garcia-Ribera
    • Eric Climent
    • Irene Piquer-Garcia
    • Raquel Corripio
    • David Sanchez-Infantes
    • Laia Villalta
    • Maria Elias
    • Josep C Jiménez-Chillarón
    • Empar Chenoll
    • Daniel Ramón
    • Lourdes Ibañez
    • Marta Ramon-Krauel
    • Carles Lerin

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 39
Population
39 children with Prader-Willi syndrome (mean age 10.4 years)
Methods
randomized crossover trial, 12-week treatment periods with placebo/BPL1 or BPL1/placebo sequences and a 12-week washout
Duration
12 weeks
Funding
Unclear
  • Rigorous Journal
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).

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