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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03032354
Enrollment
96
Registered
2017-01-26
Start date
2017-07-15
Completion date
2018-12-31
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

probiotics, children, remission

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.

Interventions

DRUGLactobacillus rhamnosus GG and Bifidobacterium lactis BB12

Combination therapy of probiotics during 6 months

OTHERPlacebo, (Placebo group)

Placebo during 6 months

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal120 min responses to a mixed meal

Secondary

MeasureTime frame
HbA1cup to 60 days from diabetes recognition, at 3th, 6th, 12th month
Weight in kilogramsup 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)at 3th, 6th, 12th month
Occurrence of other autoimmune diseasesat 12th month
Height in metersup to 60 days from diabetes recognition, and at 3th, 6th, 12th month
Insulin requirement (U / kg body mass )up 60 days from diabetes recognition, at 3th, 6th, 12th month
BMI scoreup to 60 days from diabetes recognition, and at 3th, 6th, 12th month
severe hypoglycemiaup to 60 days from diabetes recognition, at 3th, 6th, 12th month
ketoacidosisup to 60 days from diabetes recognition, at 3th, 6th, 12th month
Fasting c- peptide concentrations in ng/mlup to 60 days from diabetes recognition, and in: 6th, 12th month
BMI in kg/m2up to 60 days from diabetes recognition, and at 3th, 6th, 12th month

Contacts

Primary ContactAgnieszka Szypowska, Assoc. Prof.
agnieszka.szypowska@gmail.com+48 509928617
Backup ContactLidia Groele, PhD
lgroele@wp.pl+48 608 671 083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026