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The Effect of Probiotics on Type 1 Diabetes Mellitus in Children

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ClinicalTrials.gov Identifier: NCT03880760
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chung-Hsing Wang, China Medical University Hospital

Brief Summary:
In this study, investigators try to administer probiotics (Lactobacillus salivarius + Lactobacillus johnsonii + Bifidobacterium lactis from glac biotech Co., Ltd.) to children T1DM patients for 6 months to observe if the inhibition effect of T1DM animal model could be discerned in a short-term period from both change of serum cytokines and beta cells insulin secretion ability.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 Other: Placebo Not Applicable

Detailed Description:

Type 1 (insulin-dependent) Diabetes Mellitus (T1DM) is among the most well studied organ-specific autoimmune diseases which approximately 75% of newly diagnosed DM patients acquire this type before the age of 18. T1DM is well known for as the consequence of selective destruction of pancreatic insulin-producing beta cells within the islets of Langerhans. Basically, autoimmune reactions against beta cells may come from activation of the immune system in genetically susceptible individuals triggered by environmental factors that bear epitopes similar to those expressed by the beta cells. Several mechanisms such as molecular mimicry, metabolic stress on beta cells, cryptic epitope exposure and costimulatory molecule upregulation have been proposed but none of them could be solely responsible for the pathogenesis of T1DM. Recently, T1DM has been considered a consequence of dysregulated or over-activation of immune responses in genetically predisposed individuals, similar to other autoimmune diseases.

The rapid increase in the incidence of T1DM in developed countries including Taiwan during recent decades refers to the role of environmental factors in this disease. Candidate environmental factors influencing T1DM include various microbial and food components encountered at mucosal surfaces as well as gut mucosal parameters such as gut permeability. However, difficulty exists in characterizing the environmental factors and mechanisms in T1DM because of their complexity of interaction, the long lag period between the induction of disease trigger factors and the clinical onset of the disease. Environmental factors in T1DM seem to prevent full penetration of the disease rather than trigger it. It had been reported that high diabetes incidence in germ-free mice and an involvement of innate immune mechanisms in the disease. In this study, investigators try to administer probiotics (Lactobacillus salivarius + Lactobacillus johnsonii + Bifidobacterium lactis from glac biotech Co., Ltd.) to children T1DM patients for 6 months to see if the inhibition effect of T1DM animal model could be discerned in a short-term period from both change of serum cytokines and beta cells insulin secretion ability.

Subjects will collect blood before the test and every 3 months after the test for total 4 times. Each time the collected blood volume is about 5~8cc. A part of the blood sample will be given to the Department of laboratory medicine for the detection of hemoglobin A1c (HbA1c) and fasting blood glucose, and the other part will be centrifuged to separate serum. The serum macrophage inflammatory proteins-1beta (MIP-1β), regulated on activation, normal T cell expressed and secreted (RANTES), interleukin-8 (IL-8), interleukin-17 (IL-17), tumor necrosis factor alpha (TNF-α) and transforming growth factor beta1 (TGF-β1) concentrations will be measured by ELISA.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Probiotics or placebo group
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Probiotics on Type 1 Diabetes Mellitus in Children
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Probiotics capsule
Taking 1 L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics capsule twice a day before meals for six months.
Other: L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32
Taking 1 L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics capsule twice a day before meals for six months.

Placebo Comparator: Placebo capsule
Taking 1 placebo capsule twice a day before meals for six months.
Other: Placebo
Taking 1 placebo capsule twice a day before meals for six months.




Primary Outcome Measures :
  1. Change in percentage of HbA1c [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Subjects will draw blood once before the test. During the test, every 3 months will draw blood to 6th month, each time the blood volume is about 5 ~ 8cc to detect HbA1c and other blood biochemical values.

  2. Change in concentration of blood glucose (AC) [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    The study will require subject to record their own daily fasting blood glucose.


Secondary Outcome Measures :
  1. Change in concentration of MIP-1β [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum MIP-1β (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.

  2. Change in concentration of RANTES [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum RANTES (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.

  3. Change in concentration of IL-8 [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum IL-8 (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.

  4. Change in concentration of IL-17 [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum IL-17 (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.

  5. Change in concentration of TNF-α [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum TNF-α (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.

  6. Change in concentration of TGF-β1 [ Time Frame: From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months. ]
    Serum was isolated by extra blood draw, serum TGF-β1 (pg/ml) concentrations were measured from first blood draw to third blood draw by ELISA.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 6 to 18 years old.
  2. T1DM patients confirmed by glucagon tests and/or presence of autoantibody(ies).

Exclusion Criteria:

  1. Significant cardiac, renal and hepatic disease.
  2. The physician diagnosed the immunodeficiency or the immune function was low.
  3. Currently using probiotics supplements or had ever taken probiotics for more than one month.
  4. Currently using antibiotics or gastrointestinal medicine.
  5. Ever allergic reaction(s) to probiotics or prebiotics regimen.

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): NCT03880760


Contacts
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Contact: Chung-hsing Wang 886-4-22052121 ext 4640 d5894@mail.cmuh.org.tw
Contact: Hung-chih Lin 886-4-22052121 ext 4640 d0373@mail.cmuh.org.tw

Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Chung-hsing Wang    886-4-22052121 ext 4640    d5894@mail.cmuh.org.tw   
Contact: Hung-chih Lin    886-4-22052121 ext 4640    d0373@mail.cmuh.org.tw   
Principal Investigator: Chung-hsing Wang         
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Study Director: Hung-chih Lin China Medical University Hospital

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Responsible Party: Chung-Hsing Wang, Attending physician, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03880760     History of Changes
Other Study ID Numbers: CMUH107-REC2-036
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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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 Chung-Hsing Wang, China Medical University Hospital:
T1DM
Autoimmune diseases
Microbiota
Probiotics

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