This arm will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) once a day.

This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.

Obesity, Childhood

Bifidobacterium breve BR03 and Bifidobacterium breve B632

Placebos

AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica

BIFI-OBESE: Clinical Trial in Paediatric Obesity

BIFI-OBESE: Effect of Probiotic Bifidobacterium Breve BR03 and Bifidobacterium Breve B632 in Paediatric Obesity

Evaluate if after the treatment with probiotic there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.

Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.

Evaluate any variation of serum lipids, leptin, adiponectin, GLP1 and insulin during OGTT.

Evaluate any variation of fecal microbiome

Evaluate any variation of short-chain fatty acids in fecal samples

Evaluate new citokines and metabolites that regulates hormone metabolism.

Flavia Prodam

Assoc. Professor in Clinical Nutrition

Azienda Ospedaliero Universitaria Maggiore della Carita

In the first part of the study (Study 1, V0-V1) patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) and one group will receive a placebo for a total of 2 months of treatment. For patients who wants to continue the study there will be a cross-over study (study 2, V2-V3) after one month of wash-out.

The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.

l alanine/vėžys

BIFI-OBESE: Clinical Trial in Paediatric Obesity

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