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NCT04335656 · ClinicalTrials.gov registry record · Phase 2

Reducing Innate Inflammation in New Onset Type 1 Diabetes

A Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin.

Active
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT04335656 is a Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 60 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04335656, a Phase 2 study of Type 1 Diabetes and Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Medical College of Wisconsin.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Type 1 Diabetes Type 1 Diabetes Mellitus Type1diabetes

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Lactiplantibacillus plantarum

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-04-01
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

Medical College of Wisconsin

447 total trials

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What the Registry Record Tells You About NCT04335656

The ClinicalTrials.gov registry entry for NCT04335656 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (93% lower). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04335656 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04335656 about?

NCT04335656 is a clinical study titled "Reducing Innate Inflammation in New Onset Type 1 Diabetes". 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 inte...

What is the current status of trial NCT04335656?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-04-01. Estimated completion is 2027-12-31.

What conditions does trial NCT04335656 study?

This clinical trial studies the following conditions: Type 1 Diabetes, Type 1 Diabetes Mellitus, Type1diabetes.

What interventions are being tested in trial NCT04335656?

The interventions under investigation include: Placebo (OTHER), Lactiplantibacillus plantarum (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04335656?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04335656 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.