← Back to Search

Probiotic

Probiotics for Type 1 Diabetes

Phase 2

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years (duration of study)

Awards & highlights

Study Summary

This trial will test whether the probiotic Lactiplantibacillus plantarum 299v (Lp299v) can help people newly diagnosed with Type 1 diabetes by reducing inflammation and preserving beta cell function.

Who is the study for?

This trial is for individuals aged 3-45 recently diagnosed with Type 1 Diabetes, who have at least one diabetes autoantibody. They must not have used probiotics or antibiotics in the past month and should not be on non-insulin hyperglycemia therapies. Women of childbearing age must use birth control during the study.Check my eligibility

What is being tested?

The study tests if Lactiplantibacillus plantarum (a probiotic) can reduce inflammation and help maintain insulin-producing cell function in new Type 1 Diabetes patients by altering gut bacteria.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort, such as bloating or gas, which are common with probiotics. However, specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years (duration of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years (duration of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years (duration of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in composite inflammatory index after probiotic supplementation

Secondary outcome measures

Markers of beta cell function

Markers of systemic microbial antigen exposure

Microbial composition as measured by 16s rRNA sequencing

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Subjects will be randomized to the treatment or placebo group. The treatment is a capsule taken by mouth once a day for 6 months.

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects will be randomized to the treatment or placebo group. The placebo is a capsule taken by mouth once a day for 6 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,523 Total Patients Enrolled

Media Library

Lactiplantibacillus plantarum 299v (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04335656 — Phase 2

Type 1 Diabetes Research Study Groups: Placebo Group, Treatment Group

Type 1 Diabetes Clinical Trial 2023: Lactiplantibacillus plantarum 299v Highlights & Side Effects. Trial Name: NCT04335656 — Phase 2

Lactiplantibacillus plantarum 299v (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335656 — Phase 2

Frequently Asked Questions

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

For this particular research, are only adults being recruited?

"The age range for eligible patients in this clinical trial falls between 3 and 45 years old."

Answered by AI

What is the FDA's opinion on Lactiplantibacillus plantarum?

"Lactiplantibacillus plantarum is a safe probiotic, according to our Power scale. This is because while there is some data supporting safety, there is no efficacy data at this time."

Answered by AI

What is the maximum amount of people who can enroll in this experiment?

"That is correct. The clinical trial was posted on April 1st, 2021 and updated recently on April 8th, 2022. The study requires 60 patients from a single location."

Answered by AI

Is this research program still recruiting participants?

"The study is recruiting patients, as shown by the information available on clinicaltrials.gov. The trial was first advertised on April 1st 2021 and has been edited most recently on April 8th 2022."

Answered by AI

How can I participate in this research?

"This clinical trial is currently looking for 60 individuals that have type 1 diabetes mellitus and fall between the ages of 3-45. In order to be eligible, patients must also meet the following requirements: Be 21 days from T1D diagnosis or have a stable metabolism as assessed by a study physician, Have a maximum C-peptide level of 0.2 nmol/L, Be positive for at least one diabetes autoantibody (excluding mIAA in those who have received exogenous insulin therapy for 2 weeks or more), Be female and of childbearing potential if 18 years old or younger and willing to use"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Innate Inflammation in New Onset Type 1 Diabetes

Susanne Cabrera 2021. "Reducing Innate Inflammation in New Onset Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335656.