Reducing Innate Inflammation in New Onset Type 1 Diabetes (NCT04335656) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Reducing Innate Inflammation in New Onset Type 1 Diabetes
United States60 participantsStarted 2021-04-01
Plain-language summary
This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.
Who can participate
Age range
3 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≤ 100 days from T1D diagnosis based on ADA criteria
. \> 21 days from T1D diagnosis or metabolically stable per study physician assessment
. Males and females 3-45 years of age, inclusive, at time of screening visit
. Peak MMTT stimulated C-peptide ≥ 0.2 nmol/L
. Positive for at least 1 diabetes autoantibody (excluding mIAA in those who have received ≥ 2 weeks of exogenous insulin therapy) either through clinically obtained labs at time of diagnosis or as obtained at the screening visit
. Females of child-bearing potential (defined as any female who has reached menarche (first menses), excluding those who have had a hysterectomy or are post-menopausal and must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in composite inflammatory index after probiotic supplementation
. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age
Exclusion criteria
. Probiotic supplement use within the past month
. Antibiotic use within the past month
. Concurrent or recent (within the past 30 days of screening) use of non-insulin therapies aimed to control hyperglycemia
. Females who are pregnant or lactating
. Chronic inflammatory or autoimmune disease with exception of stable thyroid disease
. Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease (i.e., clinically obtained tissue transglutaminase IgA titers above reference range, being referred to gastroenterology for possible endoscopy, etc.)
. Use of glucocorticoids or other immunosuppressive agents within 30 days of screening MMTT
. Use of medications known to influence glucose tolerance