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Probiotic

Lactobacillus Johnsonii for Type 1 Diabetes

Phase 2
Recruiting
Led By Michael Haller
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed T1D by physician diagnosis
Able to swallow a capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial suggests that the probiotic Lactobacillus johnsonii N6.2 may help prevent or restore gut flora in people with type 1 diabetes, potentially preserving beta cell function.

Who is the study for?
This trial is for children and adolescents with Type 1 Diabetes who can swallow capsules, provide blood and stool samples, complete online questionnaires, and take C-peptide tests. They must not have gastrointestinal diseases, recent antibiotic use, heart disease, live with immunocompromised individuals or be pregnant.Check my eligibility
What is being tested?
The study is testing whether the probiotic Lactobacillus johnsonii N6.2 can help maintain gut health and support immune function in young people with Type 1 Diabetes by comparing it to a placebo capsule.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or allergic reactions for those sensitive to milk proteins (as the probiotic may contain such), but generally probiotics are considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor has diagnosed me with Type 1 Diabetes.
Select...
I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Event and/or Serious Adverse Event
Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)
Tolerance will be evaluated according to their responses on weekly questionnaires

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Probiotic GroupActive Control1 Intervention
The probiotic group will receive a daily capsule with Lactobacillus johnsonii N6.2 1x109 CFUs. Participants will consume one capsule (treatment or placebo) daily for 24 weeks.
Group II: Placebo GroupPlacebo Group1 Intervention
The placebo group will receive a capsule daily with dried skim milk (vehicle of the probiotic). Participants will consume one capsule (treatment or placebo) daily for 24 weeks.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,648 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,727 Total Patients Enrolled
Michael HallerPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

Lactobacillus johnsonii N6.2 (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03961854 — Phase 2
Type 1 Diabetes Research Study Groups: Probiotic Group, Placebo Group
Type 1 Diabetes Clinical Trial 2023: Lactobacillus johnsonii N6.2 Highlights & Side Effects. Trial Name: NCT03961854 — Phase 2
Lactobacillus johnsonii N6.2 (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961854 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of participants in this trial restricted to those over 25 years old?

"The minimum age for enrollment into this medical trial is 8, with the upper limit being 18."

Answered by AI

What potential risks do individuals face when exposed to Probiotic Group?

"Due to the lack of clinical evidence regarding probiotic group's efficacy, it was assigned a safety score of 2."

Answered by AI

Are there any opportunities for participation in this experiment at present?

"Indeed, clinicaltrials.gov demonstrates this research project's current need for participants. It was initially registered on October 10th 2019 and edited as of September 26th 2022. There are 57 patients needed to be recruited from a single medical centre."

Answered by AI

In what number of participants is this clinical trial enrolling?

"Yes, according to records on clinicaltrials.gov, this medical study is still in the process of recruiting participants. This trial was initially posted on October 10th 2019 and recently updated on September 26th 2022. 57 patients are required from a single location for the success of this experiment."

Answered by AI

What are the criteria for eligibility in this research endeavor?

"This study requires that enrollees have diabetes, an autoimmune condition and age between 8-18. There is space for 57 participants in total."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
UF Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How frequent are the visits to UF Gainsville?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Lactobacillus Johnsonii in Children and Adolescents With T1D
2019. "Lactobacillus Johnsonii in Children and Adolescents With T1D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03961854.
All > Probiotics
~10 spots leftby May 2025
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