ESPE Abstracts (2019) 92 FC15.5

Effects of Bifidobacterium animalis subsp. lactis on Children with Prader-Willi Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial

Marta Ramon-Krauel1,2, Montse Amat-Bou1,2, Sonika García-Rivera1, Raquel Corripio3,4, Lourdes Ibáñez1,2, Carles Lerin1,2


1Hospital Sant Joan de Déu, Barcelona, Spain. 2Institut de Recerca Sant Joan de Déu, Barcelona, Spain. 3Parc Taulí Hospital Universitari, Sabadell, Spain. 4Research and Innovation Institute Parc Taulí (I3PT), Sabadell, Spain


The gut microbiome has recently emerged as a major contributor to obesity and metabolic disease. Specifically, Bifidobacterium animalis sups. lactis (BAL) has shown promise for obesity treatment in human subjects, improving body composition and metabolic health. Moreover, tryptophan metabolism, a crucial regulator of satiety mechanisms and anxiety, is a main target of BAL. Given that clinical manifestations of Prader-Willi syndrome (PWS) include hyperphagia, anxiety, altered body composition, and metabolic dysregulation, we tested whether daily supplementation with BAL could prove beneficial for children with PWS.

To this aim, 28 children with genetic diagnosis of PWS (4.5 to 18 year-old, 17 female, mean±SD BMI-SDS 1.57±1.34) were provided with BAL (daily dose of 10^10 cfu) and placebo for 3 months per treatment phase using a randomized double-blind crossover design, with a 3-month washout period between phases. Anthropometric, biochemical, and psychological data as well as biological samples (feces, blood) were obtained at the beginning and end of each phase. The main outcome variable was body composition (percent adiposity), measured by DXA scan. Hyperphagia was assessed with a specific questionnaire for PWS (HQ-CT) and nutritional analysis with a 4-day food record. Emotional and behavioral problems were assessed with a parental-rated validated questionnaire (CBCL) for children between 8 and 18 years of age (n=20). Placebo and probiotic phases were compared using Wilcoxon signed-rank test (for paired samples). No significant carry-over effects were observed.

Daily consumption of BAL significantly decreased percent of abdominal adiposity compared to placebo period (P<0.05). Furthermore, treatment with the probiotic improved fasting insulin levels and HOMA-IR (P<0.05 for both). Other outcome measures, including BMI-SDS, blood pressure, and lipid profile, did not differ between treatment phases. No effect of BAL supplementation was observed on hyperphagia and caloric intake. The CBCL test revealed no changes in anxiety levels but improvements in social withdrawal scores after probiotic supplementation compared to placebo (P<0.05). In summary, our data indicates that supplementation with BAL improves abdominal adiposity, insulin resistance, and could ameliorate some behavioral problems in children with PWS. A follow-up study with a longer treatment period will be warranted to determine whether BAL supplementation could provide a strategy for improving long-term health outcomes in children with PWS.

This trial was registered at clinicaltrials.gov as NCT03548480.

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