Probiotics in Newly Recognized Type 1 Diabetes

Phase 4

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Placebo, (Placebo group); Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12

• Registration Number: NCT03032354
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-11
• Study Start: 2017-07-15
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm: Placebo group	Placebo, (Placebo group)	Placebo - maltodextrin
Probiotics arm: Probiotics group	Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12	combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Insulin requirement (U / kg body mass )	up 60 days from diabetes recognition, 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 score	up to 60 days from diabetes recognition, and 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
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
BMI in kg/m2	up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Fasting c- peptide concentrations in ng/ml	up to 60 days from diabetes recognition, and in: 6th, 12th month