Probiotics in Newly Recognized Type 1 Diabetes

Medical University of Warsaw

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12; Other: Placebo, (Placebo group)

Study type: Interventional

Funder types: Other

Identifiers

NCT03032354

AgaLidka

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Probiotics arm: Probiotics group

Experimental group

Description:

combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule

Treatment:

Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12

Placebo arm: Placebo group

Placebo Comparator group

Description:

Placebo - maltodextrin

Treatment:

Other: Placebo, (Placebo group)