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NCT04141761 · ClinicalTrials.gov registry record · Phase 2

Probiotics in Newly Diagnosed T1D

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
43
Enrollment target
1
Study location

NCT04141761 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 43 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04141761, 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
43 participants
Enrollment target
1
Study location

Study Summary

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. 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 Visbiome

Study Locations (1)

Wisconsin

  • Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2019-04-01
Est. Completion 2027-06-30
Phase Phase 2

Sponsor

Medical College of Wisconsin

447 total trials

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What the Registry Record Tells You About NCT04141761

The ClinicalTrials.gov registry entry for NCT04141761 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 43 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 (95% 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.

NCT04141761 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT04141761 about?

NCT04141761 is a clinical study titled "Probiotics in Newly Diagnosed T1D". The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of...

What is the current status of trial NCT04141761?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2019-04-01. Estimated completion is 2027-06-30.

What conditions does trial NCT04141761 study?

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

What interventions are being tested in trial NCT04141761?

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

Who is sponsoring clinical trial NCT04141761?

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

Where is trial NCT04141761 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.