Conditions Influencing Health Status Clinical Trial
Official title:
Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults
The present report describes the design of a clinical trial performed on healthy adult
individuals to check whether the daily intake of the new Hero strains contribute to
intestinal colonization, under safe and tolerable conditions, with a positive contribution
to health and wellbeing of healthy individuals.
Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036),
increases intestinal microbiota in healthy adults, being safe and well tolerated. The
regular intake has positive effects on the gastrointestinal and immune system.
The project will be based on a double-blind, randomized, and placebo-controlled clinical
trial. It will be multi-Centre, with four groups plus a control group.
The colonization performed by the strains and the modification of the intestinal microbiota
will be evaluated by means of strain identification with RT-PCR equipped with specific
primers, and bacterial population counting with in situ immunofluorescence techniques.
The safety of strain intake will be evaluated with physical examination, blood parameters,
and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora.
Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the
record of aspect and frequency of faeces.
The effect on the systemic and adaptive immune system will be measured by means of
lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and
faeces. Also AGCC on faeces.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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