Probiotics in Newly Recognized Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
Placebo, (Placebo group)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring probiotics, children, remission
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics arm: Probiotics group
Placebo arm: Placebo group
Arm Description
combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule
Placebo - maltodextrin
Outcomes
Primary Outcome Measures
Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal
Secondary Outcome Measures
Insulin requirement (U / kg body mass )
HbA1c
Weight in kilograms
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment ( eg.abdominal pain, diarrhea , constipation , vomiting,flatulence)
Occurrence of other autoimmune diseases
Height in meters
BMI in kg/m2
BMI score
severe hypoglycemia
ketoacidosis
Fasting c- peptide concentrations in ng/ml
Full Information
NCT ID
NCT03032354
First Posted
January 5, 2017
Last Updated
July 6, 2017
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT03032354
Brief Title
Probiotics in Newly Recognized Type 1 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
probiotics, children, remission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics arm: Probiotics group
Arm Type
Experimental
Arm Description
combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule
Arm Title
Placebo arm: Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo - maltodextrin
Intervention Type
Drug
Intervention Name(s)
Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
Other Intervention Name(s)
Probiotics
Intervention Description
Combination therapy of probiotics during 6 months
Intervention Type
Other
Intervention Name(s)
Placebo, (Placebo group)
Other Intervention Name(s)
Maltodextrin
Intervention Description
Placebo during 6 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Insulin requirement (U / kg body mass )
Time Frame
up 60 days from diabetes recognition, at 3th, 6th, 12th month
Title
HbA1c
Time Frame
up to 60 days from diabetes recognition, at 3th, 6th, 12th month
Title
Weight in kilograms
Time Frame
up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Title
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
Title
Occurrence of other autoimmune diseases
Time Frame
at 12th month
Title
Height in meters
Time Frame
up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Title
BMI in kg/m2
Time Frame
up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Title
BMI score
Time Frame
up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Title
severe hypoglycemia
Time Frame
up to 60 days from diabetes recognition, at 3th, 6th, 12th month
Title
ketoacidosis
Time Frame
up to 60 days from diabetes recognition, at 3th, 6th, 12th month
Title
Fasting c- peptide concentrations in ng/ml
Time Frame
up to 60 days from diabetes recognition, and in: 6th, 12th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Szypowska, Assoc. Prof.
Phone
+48 509928617
Email
agnieszka.szypowska@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Groele, PhD
Phone
+48 608 671 083
Email
lgroele@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnieszka Szypowska, Assoc. Prof.
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Probiotics in Newly Recognized Type 1 Diabetes
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