NCT03880760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

March 13, 2019

Last Update Submit

August 2, 2021

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DMAutoimmune diseasesMicrobiotaProbiotics

Outcome Measures

Primary Outcomes (2)

  • Change in percentage of HbA1c

    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.

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • Change in concentration of blood glucose (AC)

    The study will require subject to record their own daily fasting blood glucose.

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

Secondary Outcomes (6)

  • Change in concentration of MIP-1β

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • Change in concentration of RANTES

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • Change in concentration of IL-8

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • Change in concentration of IL-17

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • Change in concentration of TNF-α

    From date of first blood draw after entering the trial until the date of third blood draw, assessed up to 6 months.

  • +1 more secondary outcomes

Study Arms (2)

Probiotics capsule

EXPERIMENTAL

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

Placebo capsule

PLACEBO COMPARATOR

Taking 1 placebo capsule twice a day before meals for six months.

Other: Placebo

Interventions

L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32OTHER

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.

Probiotics capsule
PlaceboOTHER

Taking 1 placebo capsule twice a day before meals for six months.

Placebo capsule

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Related Publications (1)

  • Wang CH, Yen HR, Lu WL, Ho HH, Lin WY, Kuo YW, Huang YY, Tsai SY, Lin HC. Adjuvant Probiotics of Lactobacillus salivarius subsp. salicinius AP-32, L. johnsonii MH-68, and Bifidobacterium animalis subsp. lactis CP-9 Attenuate Glycemic Levels and Inflammatory Cytokines in Patients With Type 1 Diabetes Mellitus. Front Endocrinol (Lausanne). 2022 Mar 1;13:754401. doi: 10.3389/fendo.2022.754401. eCollection 2022.

    PMID: 35299968DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Study Officials

  • Hung-chih Lin

    China Medical University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Probiotics or placebo group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 19, 2019

Study Start

August 1, 2018

Primary Completion

October 31, 2020

Study Completion

January 31, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

TW(1)