Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study
Abstract
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: Multiple Sclerosis.
Primary outcome: number of gad-enhancing lesions in T1; number of lesions in T1 and new lesions in T2.
Enrollment: 80 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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