NCT03032354

Probiotics in Newly Recognized Type 1 Diabetes

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12	Combination therapy of probiotics during 6 months
OTHER	Placebo, (Placebo group)	Placebo during 6 months

Timeline

• Start date: 2017-07-15
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-01-26
• Last updated: 2017-07-11