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Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

NCT00202410 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-05-19

No results posted yet for this study

Summary

The frequency of auto-immune diseases (including multiple sclerosis) is increasing in industrialised countries.

According to an hypothesis which is receiving a wide international credit, this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics.

If exposure to microbes is lacking, also their regulatory function is missed with a consequent possible onset of auto-immune symptoms.

For this reason, it is deemed that by exposing the immune system of a patient to an ancient microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium, it is possible to rebalance the immune system.

Conditions

Interventions

BIOLOGICAL

Bacille of Calmette-Guerin

A single intracutaneous dose of 0.1 mL freeze-dried BCG (1 mg/mL; Berna Institute, Basel).

OTHER

placebo

subcutaneous administration of physiologic solution

Sponsors & Collaborators

  • Italian Multiple Sclerosis Foundation

    collaborator OTHER

  • Istituto Superiore di Sanità

    collaborator OTHER

  • S. Andrea Hospital

    lead OTHER

Principal Investigators

  • Marco Salvetti, Professor · S.Andrea Hospital, University of Rome "La Sapienza"

  • Giovanni Ristori, MD · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2007-09-30
Completion
2008-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202410 on ClinicalTrials.gov