Effect of iron supplementation on psychomotor development of non-anemic exclusively or predominantly breastfed infants: randomized, controlled trial.

Current research suggests that the interaction between the gut microflora and the immune system may be a factor in the development of type 1 diabetes. Changes in the composition of the gut microflora observed in patients with type 1 diabetes may increase intestinal permeability. Greater exposure to the immune system of food antigens and microbiota-derived products may cause a pro-inflammatory response and stimulate beta-cell autoimmunity in genetically predisposed individuals. The aim of the study is to assess whether the supplementation of probiotic bacteria Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 has a positive effect on the function of pancreatic beta cells in children with newly diagnosed type 1 diabetes. Expected results: The results of this randomized controlled trial, both positive and negative, will lead to further recommendations on the use of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 to improve beta cell function in children with newly diagnosed type 1 diabetes. Primary endpoint: areas under the curve the level of the C-peptide of the peptide after stimulation. Secondary endpoints: fasting C-peptide concentration, insulin requirement, HbA1c, interleukins, intestinal permeability, anthropometric parameters, side effects, occurrence of other autoimmune diseases, acute diabetes complications. The protocol has been registered ClinicalTrials.gov. NCT03032354 and published BMJ Open. 2017 Oct 11;7(10):e017178. doi: 10.1136/bmjopen-2017-017178.