Clinical trial NCT03961347: Lactobacillus Johnsonii Supplementation in Adults With T1D
Official title: Evaluation of Safety, Tolerability and Immunological Responses to Lactobacillus Johnsonii N6.2 Supplementation in Adults With Diabetes Type 1
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: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: 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 in subjects between 18-45 years old with T1D.
Primary purpose: SUPPORTIVE_CARE

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 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 or placebo capsule daily for 24 weeks.
* Are willing to provide stool samples throughout the study.
* Are willing to provide blood samples throughout the study.
* Are willing to take three 2-hour Mixed-Meal Tolerance Tests (MMTTs).
* Are able to access a computer with Internet throughout the study.\*

  * Note: Going into the study, we want the participants to have daily internet access. However, if this changes once they are in the study, we will provide paper copies of the questionnaires.

Exclusion Criteria:

* Have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.).
* Have chronic disease kidney disease.
* Have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, transplant patient, 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: