NCT00011141

Completed

Lactobacillus Plantarum as Therapy for NK-T Cell Deficiency

National Center for Research Resources (NCRR)Source

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Other study identifiers

Sponsor study identifier

NCRR-M01RR06020-0165

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

Not reported

Date not reported

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 12, 2001
Actual (reported)
First Posted
February 14, 2001
Actual (reported)

Last Updated: June 24, 2005
Status Verified: December 2003
Last Update Submitted: June 23, 2005

Conditions

Diabetes Mellitus

Keywords

Immune-mediated diabetes mellitus

Interventions

Oral lactobacillus administrationDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

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Sponsors & Collaborators

National Center for Research Resources (NCRR)
NIHlead

Study Sites (1)

Cornell University

New York, New York, 10021, United States

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

Source record

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Source: ClinicalTrials.gov.

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