Probiotics in Newly Recognized Type 1 Diabetes

NCT03032354 | Unknown Phase 4

• 1 other identifier: AgaLidka
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

probiotics; children; remission

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) during fasting and at 30,60,90,120 min following the start of the meal

  120 min responses to a mixed meal

Secondary Outcomes (11)

• Insulin requirement (U / kg body mass )

  up 60 days from diabetes recognition, at 3th, 6th, 12th month

• HbA1c

  up to 60 days from diabetes recognition, at 3th, 6th, 12th month

• Weight in kilograms

  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)

  at 3th, 6th, 12th month

• Occurrence of other autoimmune diseases

  at 12th month

Study Arms (2)

Probiotics arm: Probiotics group

EXPERIMENTAL

combination of probiotics: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 in the same capsule

Drug: Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12

Placebo arm: Placebo group

PLACEBO COMPARATOR

Placebo - maltodextrin

Other: Placebo, (Placebo group)

Interventions

Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 DRUG

Combination therapy of probiotics during 6 months

Also known as: Probiotics

Probiotics arm: Probiotics group

Placebo, (Placebo group) OTHER

Placebo during 6 months

Also known as: Maltodextrin

Placebo arm: Placebo group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Antibiotic-therapy during last 4 weeks
• Taking of probiotics during last 2 weeks
• Intestinal infection during last 2 weeks
• Intestinal chronic diseases

Sponsors & Collaborators

• Medical University of Warsaw: lead

Related Publications (27)

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• Groele L, Szajewska H, Szalecki M, Swiderska J, Wysocka-Mincewicz M, Ochocinska A, Stelmaszczyk-Emmel A, Demkow U, Szypowska A. Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e001523. doi: 10.1136/bmjdrc-2020-001523.

  PMID: 33771763 DERIVED

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Agnieszka Szypowska, Assoc. Prof.

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Szypowska, Assoc. Prof.

CONTACT

+48 509928617; agnieszka.szypowska@gmail.com

Lidia Groele, PhD

CONTACT

+48 608 671 083; lgroele@wp.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 26, 2017
• Study Start: July 15, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share