Lactobacillus Johnsonii in Children and Adolescents With T1D

Type 1 Diabetes (T1D) Clinical Trial

Official title:

Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961854
• Other study ID #: IRB201901369
• Secondary ID: 2-SRA-2019-811-M
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2019
• Est. completion date: May 18, 2025

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: Michael Haller, MD
• Phone: 352-273-9264
• Email: hallemj[@]peds.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: May 18, 2025
• Est. primary completion date: May 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes (T1D)

Intervention

Drug:
• L. johnsonii Probiotic
Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
• Placebo Capsule
Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.

Locations

Country	Name	City	State
United States	UF Clinical Research Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)	CBC and CMP will be evaluated at four different time points during study: 1st measure will be at screening visit and before starting intervention (visit 1/week -4, baseline period), 2nd measure will be after 12 weeks after starting intervention (visit 2/ week 12), 3rd measure will be after the 24 weeks of intervention (visit 3/ week 24) and the 4th measure will be 24 weeks later, end of washout period (visit 4/week 48). Values should be within the normal values except for glucose.	52 weeks
Primary	Tolerance will be evaluated according to their responses on weekly questionnaires	The weekly questionnaire will ask participants to respond to questions regarding their gastrointestinal health (bowel movement frequency, gastrointestinal and other symptoms (i.e., constipation, diarrhea, stomach pain) and general wellness (if you consumed an antibiotic, visited a doctor, etc.). The questionnaires follow a scale from 1-7, 1 = No discomfort at all, 7 = Very severe discomfort.	52 weeks
Primary	Adverse Event and/or Serious Adverse Event	Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24 hrs., in particular gastro-intestinal symptoms, fever and rashes.	24 weeks