Probiotics in Newly Recognized Type 1 Diabetes

July 6, 2017 updated by: Hanna Szajewska, Medical University of Warsaw

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lidia Groele, PhD
  • Phone Number: +48 608 671 083
  • Email: lgroele@wp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics arm: Probiotics group
combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule
Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12
Combination therapy of probiotics during 6 months
Other Names:
  • Probiotics
Placebo Comparator: Placebo arm: Placebo group
Placebo - maltodextrin
Other: Placebo, (Placebo group)
Placebo during 6 months
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
120 min responses to a mixed meal

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin requirement (U / kg body mass )
Time Frame: up 60 days from diabetes recognition, at 3th, 6th, 12th month
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
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
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
at 3th, 6th, 12th month
Occurrence of other autoimmune diseases
Time Frame: at 12th month
at 12th month
Height in meters
Time Frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month
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
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
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
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
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
up to 60 days from diabetes recognition, and in: 6th, 12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Agnieszka Szypowska, Assoc. Prof., Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AgaLidka

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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