A Phase 4 interventional study of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 and Placebo, (Placebo group) in Diabetes Mellitus, Type 1, sponsored by Medical University of Warsaw. Status unknown. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Treatment
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.
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 96 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule
Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
Placebo - maltodextrin
Other: Placebo, (Placebo group)
Combination therapy of probiotics during 6 months
Also known as: Probiotics
Placebo during 6 months
Also known as: Maltodextrin
Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal
Time frame: 120 min responses to a mixed meal
Insulin requirement (U / kg body mass )
Time frame: up 60 days from diabetes recognition, at 3th, 6th, 12th month
HbA1c
Time frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month
Weight in kilograms
Time frame: 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)
Time frame: at 3th, 6th, 12th month
Occurrence of other autoimmune diseases
Time frame: at 12th month
Height in meters
Time frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
BMI in kg/m2
Time frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
BMI score
Time frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
severe hypoglycemia
Time frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month
ketoacidosis
Time frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month
Fasting c- peptide concentrations in ng/ml
Time frame: up to 60 days from diabetes recognition, and in: 6th, 12th month
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2017; primary completion for Dec 2018, 17 months later.
Of 63 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's planned 17 months is below that.
Counting every sponsor, half of 74 studies reached it within 22 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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