Lactobacillus Johnsonii in Children and Adolescents With T1D

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

Inclusion Criteria:

• have been diagnosed with T1D for less than 1 year

• 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)

• have a Peak C-peptide >0.2 pmol/mL (0.6ng/mL)

• are positive for at least one autoantibody (ICA, GAD-65, ZnT8 and IA-2A)

• 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.