Clinical trial NCT03961854: Lactobacillus Johnsonii in Children and Adolescents With T1D
Official title: Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Type 1 Diabetes (T1D)
Keywords: probiotics
genetics
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2019-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blinded, placebo-controlled clinical trial will be carried out with children and adolescents (8-less than 18 years old) with T1D
Primary purpose: PREVENTION

Brief summary: While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.


Eligibility criteria: Inclusion Criteria:

* have confirmed T1D by physician diagnosis
* have normal values at screening for complete blood count (CBC) and complete metabolic profiles (with the exception of fasting glucose and HbA1c)
* are able to swallow a capsule
* are willing to complete weekly online questionnaires
* are willing to consume a probiotic
* are willing to provide stool samples throughout the study
* are willing to provide blood samples throughout the study
* are willing to take three stimulated C-peptide tests
* are able to access a computer with Internet throughout the study

Exclusion Criteria:

* being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
* being treated for chronic kidney disease
* have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, organ transplant, Lupus, DiGeorge syndrome, selective deficiency of IgA, Bruton's disease etc.)
* have an underlying structural heart disease
* currently live with an immunocompromised person
* are currently taking medications for constipation and/or diarrhea
* have taken antibiotics within the past 2 weeks prior to randomization
* are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start
* are a current smoker
* are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months
* have a known allergy to milk or milk protein.

Primary outcomes:
measure: Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)
timeFrame: 52 weeks
measure: Tolerance will be evaluated according to their responses on weekly questionnaires
timeFrame: 52 weeks
measure: Adverse Event and/or Serious Adverse Event
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Michael Haller
role: PRINCIPAL_INVESTIGATOR
References: