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Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00011141
First received: February 12, 2001
Last updated: June 23, 2005
Last verified: December 2003
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

  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

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

Keywords provided by National Center for Research Resources (NCRR):
Immune-mediated diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013