Probiotics in Newly Recognized Type 1 Diabetes

Study Overview
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Brief Summary
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They are major genera of bacteria that make up the colon flora in human, constitute intestinal microbial homeostasis, inhibit growth of pathogens, improve the gut mucosal barrier and modulate local and systemic immune responses. Changes in gut microbiota can influence the immune system by increasing gut permeability, intestinal inflammation, and impaired oral tolerance in type 1 diabetes.Taken together, the data imply that bacteriotherapy may potentially be used as a tool to modulate the immune system for preventing islet destruction. Supplementation of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 improved blood glucose control in normoglycaemic pregnant women and reduced the frequency of gestational diabetes mellitus Aim of the study: The effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomized, double blind, placebo-controlled trial. Primary end point: Area under the curve (AUC) of c-peptide level during during fasting and at 30,60,90,120 min following the start of the meal Intervention: Included patients will be randomly assigned to receive a combination of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (Probiotics Group ) or placebo (Placebo Group ) during six months. The expected results: Beneficial effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 on beta-cell function shown in the properly performed, methodologically accurate study would create a rationale for its routine use in patients with newly diagnosed type 1 diabetes.

Detailed Description
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Intervention: At the 6-month follow-up visit will be evaluated adherence and occurrence of side effects of the study procedure. The outcome measures will be assessed at the beginning of the study, and at the 6 and 12-month follow-up visit.

Official Title
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Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Lactis BB 12 on Beta-cell Function in Children With Newly Diagnosed Type 1 Diabetes - a Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
* Other: Placebo, (Placebo group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes confirmed by clinical history and the presence of at least one positive autoantibody: anti-glutamic acid decarboxylase (anti-GAD), islet antigen 2 (IA2), islet cell antibody ( ICA) Fasting c-peptide level >/= 0.4 ng/ml The diagnosis of diabetes during the last 60 days Consent to participate in the study Exclusion Criteria: Antibiotic-therapy during last 4 weeks Taking of probiotics during last 2 weeks Intestinal infection during last 2 weeks Intestinal chronic diseases

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics arm: Probiotics group<br>combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule | Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12<br>* Combination therapy of probiotics during 6 months<br>* Other names: Probiotics;|
| Placebo Comparator: Placebo arm: Placebo group<br>Placebo - maltodextrin | Other: Placebo, (Placebo group)<br>* Placebo during 6 months<br>* Other names: Maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal |  | 120 min responses to a mixed meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin requirement (U / kg body mass ) |  | up 60 days from diabetes recognition, at 3th, 6th, 12th month | 
| HbA1c |  | up to 60 days from diabetes recognition, at 3th, 6th, 12th month | 
| Weight in kilograms |  | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month | 
| Number of participants with abnormal laboratory values and/or adverse events that are related to treatment ( eg.abdominal pain, diarrhea , constipation , vomiting,flatulence) |  | at 3th, 6th, 12th month | 
| Occurrence of other autoimmune diseases |  | at 12th month | 
| Height in meters |  | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month | 
| BMI in kg/m2 |  | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month | 
| BMI score |  | up to 60 days from diabetes recognition, and at 3th, 6th, 12th month | 
| severe hypoglycemia |  | up to 60 days from diabetes recognition, at 3th, 6th, 12th month | 
| ketoacidosis |  | up to 60 days from diabetes recognition, at 3th, 6th, 12th month | 
| Fasting c- peptide concentrations in ng/ml |  | up to 60 days from diabetes recognition, and in: 6th, 12th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, children, remission