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Probiotics in Newly Recognized Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032354
Recruitment Status : Unknown
Verified January 2017 by Hanna Szajewska, Medical University of Warsaw.
Recruitment status was:  Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 Other: Placebo, (Placebo group) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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 Name: Probiotics
Placebo Comparator: Placebo arm: Placebo group
Placebo - maltodextrin
 Other: Placebo, (Placebo group)
Placebo during 6 months
Other Name: Maltodextrin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Insulin requirement (U / kg body mass ) [ Time Frame: up 60 days from diabetes recognition, at 3th, 6th, 12th month ]
  2. HbA1c [ Time Frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month ]
  3. Weight in kilograms [ Time Frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month ]
  4. 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 ]
  5. Occurrence of other autoimmune diseases [ Time Frame: at 12th month ]
  6. Height in meters [ Time Frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month ]
  7. BMI in kg/m2 [ Time Frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month ]
  8. BMI score [ Time Frame: up to 60 days from diabetes recognition, and at 3th, 6th, 12th month ]
  9. severe hypoglycemia [ Time Frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month ]
  10. ketoacidosis [ Time Frame: up to 60 days from diabetes recognition, at 3th, 6th, 12th month ]
  11. Fasting c- peptide concentrations in ng/ml [ Time Frame: up to 60 days from diabetes recognition, and in: 6th, 12th month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032354


Contacts
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Contact: Agnieszka Szypowska, Assoc. Prof. +48 509928617 agnieszka.szypowska@gmail.com
Contact: Lidia Groele, PhD +48 608 671 083 lgroele@wp.pl

Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Agnieszka Szypowska, Assoc. Prof. Medical University of Warsaw
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hanna Szajewska, Prof., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03032354    
Other Study ID Numbers: AgaLidka
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanna Szajewska, Medical University of Warsaw:
probiotics
children
remission
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases