NCT00011141

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

February 12, 2001

Last Update Submit

June 23, 2005

Conditions

Keywords

Immune-mediated diabetes mellitus

Interventions

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 12, 2001

First Posted

February 14, 2001

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations