The Effect of Probiotics on Type 1 Diabetes Mellitus in Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In this study, investigators try to administer probiotics (Lactobacillus salivarius +
      Lactobacillus johnsonii + Bifidobacterium lactis from glac biotech Co., Ltd.) to children
      T1DM patients for 6 months to observe if the inhibition effect of T1DM animal model could be
      discerned in a short-term period from both change of serum cytokines and beta cells insulin
      secretion ability.
    

Detailed description: 
      Type 1 (insulin-dependent) Diabetes Mellitus (T1DM) is among the most well studied
      organ-specific autoimmune diseases which approximately 75% of newly diagnosed DM patients
      acquire this type before the age of 18. T1DM is well known for as the consequence of
      selective destruction of pancreatic insulin-producing beta cells within the islets of
      Langerhans. Basically, autoimmune reactions against beta cells may come from activation of
      the immune system in genetically susceptible individuals triggered by environmental factors
      that bear epitopes similar to those expressed by the beta cells. Several mechanisms such as
      molecular mimicry, metabolic stress on beta cells, cryptic epitope exposure and costimulatory
      molecule upregulation have been proposed but none of them could be solely responsible for the
      pathogenesis of T1DM. Recently, T1DM has been considered a consequence of dysregulated or
      over-activation of immune responses in genetically predisposed individuals, similar to other
      autoimmune diseases.

      The rapid increase in the incidence of T1DM in developed countries including Taiwan during
      recent decades refers to the role of environmental factors in this disease. Candidate
      environmental factors influencing T1DM include various microbial and food components
      encountered at mucosal surfaces as well as gut mucosal parameters such as gut permeability.
      However, difficulty exists in characterizing the environmental factors and mechanisms in T1DM
      because of their complexity of interaction, the long lag period between the induction of
      disease trigger factors and the clinical onset of the disease. Environmental factors in T1DM
      seem to prevent full penetration of the disease rather than trigger it. It had been reported
      that high diabetes incidence in germ-free mice and an involvement of innate immune mechanisms
      in the disease. In this study, investigators try to administer probiotics (Lactobacillus
      salivarius + Lactobacillus johnsonii + Bifidobacterium lactis from glac biotech Co., Ltd.) to
      children T1DM patients for 6 months to see if the inhibition effect of T1DM animal model
      could be discerned in a short-term period from both change of serum cytokines and beta cells
      insulin secretion ability.

      Subjects will collect blood before the test and every 3 months after the test for total 4
      times. Each time the collected blood volume is about 5~8cc. A part of the blood sample will
      be given to the Department of laboratory medicine for the detection of hemoglobin A1c (HbA1c)
      and fasting blood glucose, and the other part will be centrifuged to separate serum. The
      serum macrophage inflammatory proteins-1beta (MIP-1β), regulated on activation, normal T cell
      expressed and secreted (RANTES), interleukin-8 (IL-8), interleukin-17 (IL-17), tumor necrosis
      factor alpha (TNF-α) and transforming growth factor beta1 (TGF-β1) concentrations will be
      measured by ELISA.
    

Intervention name(s): L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32; Placebo
Intervention type(s): Other; Other
Intervention description(s): Taking 1 L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics capsule twice a day before meals for six months.; Taking 1 placebo capsule twice a day before meals for six months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Probiotics or placebo group
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: T1DM; Autoimmune diseases; Microbiota; Probiotics