Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The etiology of immune-mediated diabetes mellitus (IMD) remains unclear. However, previous studies indicate that autoimmunity may be a result of dysfunction of natural killer T cells (NK-T cells). Newly diagnoses patients with IMD have been shown in our laboratory to have significantly lower NK-T cells than normal controls. Other studies have shown that oral administration of lactobacillus can boost NK-T cell activity in children with HIV without side effects. Our objective is to evaluate the effect of lactobacillus administration on NK-T cell activity in patients with IMD

Detailed Description

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Conditions

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Diabetes Mellitus

Keywords

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Immune-mediated diabetes mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oral lactobacillus administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes

Minimum Eligible Age

1 Year

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Cornell University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NCRR-M01RR06020-0165

Identifier Type: -

Identifier Source: org_study_id