Effect of probiotics on the occurrence of nutrition absorption capacities in healthy children: a randomized double-blinded placebo-controlled pilot study

A. Ballini, A. Gnoni, D. De Vito, G. Dipalma, S. Cantore, C. Gargiulo Isacco, R. Saini, L. Santacroce, S. Topi, A. Scarano, S. Scacco, F. Inchingolo

Department of Biosciences, Biotechnologies and Biopharmaceutics, University of Bari “Aldo Moro”, Bari, Italy. salvatore.scacco@uniba.it

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• Pharmacology

OBJECTIVE: Recent advances in the translational research showed that dietary nutrients have critical importance to the microbioma balance in the gastrointestinal tract. Therefore, the alteration of the intestinal microbiota in order to achieve, restore, and maintain favorable balance in the ecosystem, and the activity of microorganisms present in the gastrointestinal tract is necessary for the improved health condition of the host. The objective of this translational study was to evaluate, in a pediatric population, the efficacy and safety of prophylactic probiotics for a better nutritional absorption capacity in the view to enhance their overall health and immunity.

PATIENTS AND METHODS: A total of 40 pediatric patients between the ages of 14 and 18 years were enrolled in the study and divided under two categories (treated/active group and placebo group). Three-time points clinical evaluations were performed: a baseline assessment (Time 0), a second evaluation at 5 weeks after the start of probiotic use (Time 1), and a final evaluation at the timeline after 10 weeks (Time 2). In the initial phase of the study, the recruited subjects underwent a panel of initial T0 clinical tests. For each of the patients, a blood sample was taken in order to evaluate the following biochemical measurements: Vitamin D, Vitamin A, Calcium, Zinc, and Iron. Moreover, an initial nutritional evaluation was carried out through which the nutritionist estimated the body composition of the subject (weight and body mass index), the caloric needs and dietary behaviour of each recruited patient.

RESULTS: Eligible participants were randomized into placebo (n = 20) or treated/active (n = 20) treatment conditions by random allocation using a computerized random number generator, ensuring all investigators remained blind to the treatment distribution. The data were compared within and between groups using statistical methods. The results confirmed that the probiotic supplementation was effective in increasing the overall blood biomarkers levels of vitamins, calcium, and mineral absorption from baseline to 10 weeks of treatment, compared with the placebo.

CONCLUSIONS: Probiotics may be suggested as supplements to improve biomarkers serum concentration if administered for a period of at least ≥ 5 weeks. However, further studies are required for optimal recommendations in patient treatment.

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