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

Tracking Information
First Received Date ^ICMJE	February 12, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00011141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency
Official Title ^ICMJE	Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Drug: Oral lactobacillus administration
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Recently diagnosed (within the last 6 months) patients with immune-mediated (type 1) diabetes
Gender	Both
Ages	1 Year to 95 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00011141
Other Study ID Numbers ^ICMJE	NCRR-M01RR06020-0165
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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