Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

This study has been completed.

First Received: February 12, 2001 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00011141

Purpose

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

Condition	Intervention
Diabetes Mellitus	Drug: Oral lactobacillus administration

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	1 Year to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011141

Locations

United States, New York
Cornell University
New York, New York, United States, 10021

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR06020-0165
Study First Received:	February 12, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00011141 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

Immune-mediated diabetes mellitus

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 11, 2009