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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 96
- 主要终点
- Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Antibiotic-therapy during last 4 weeks
- •Taking of probiotics during last 2 weeks
- •Intestinal infection during last 2 weeks
- •Intestinal chronic diseases
研究组 & 干预措施
Probiotics arm: Probiotics group
combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule
干预措施: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 (Drug)
Placebo arm: Placebo group
Placebo - maltodextrin
干预措施: Placebo, (Placebo group) (Other)
结局指标
主要结局
Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal
时间窗: 120 min responses to a mixed meal
次要结局
- 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)
研究者
Hanna Szajewska
Prof.
Medical University of Warsaw