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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
103
Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
9x10E9 cfu (colony forming unit) per day during 28 days.
9x10E9 cfu (colony forming unit) per day during 28 days.
Granada University
Granada, Granada, Spain
Hero Institute of Infant Nutrition
Alcantarilla, Murcia, Spain
Murcia University
Espinardo, Murcia, Spain
Valencia University
Valencia, Valencia, Spain
Gastrointestinal Tolerance After Probiotic Consumption.
Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the "number of participants" was tolerant to the intervention.
Time frame: 4 weeks of the treatments. Daily recorded.
Gastrointestinal and Immune Effects of Probiotics Consumption.
Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks). Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period).
Time frame: At Time zero, after 4 weeks, and 2 later.
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9x10E9 cfu (colony forming unit) per day during 28 days.
Placebo capsule for 28 days.