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The prevailing notion that the deliberate intake of viable cells of certain microorganisms through food and supplements may be beneficial for health underlies the worldwide commercial success of probiotic products.
Probiotics have been defined as “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host” (1).
In addition, participants compiled a weekly Bristol stool chart to report their bowel habits.
The intestinal microbiota has been proposed as an additional organ of the human body that performs numerous functions, ranging from vitamin production and immunomodulation to improvement of nutrient bioavailability and competitive exclusion against potential detrimental microorganisms (5).
Therefore, modification of the intestinal microbial ecosystem (IME) may potentially induce functional changes that affect host physiology (5) and is generally recognized by certain health agencies (e.g., Italian Ministry of Health and Health Canada Federal Department) as the primary element supporting probiotic efficacy.
Participants in the study were prohibited from eating probiotic foods and supplements and any foods or supplements enriched in prebiotic compounds. The PROBIOTA-Bb study was a randomized, double-blind, and placebo-controlled crossover trial with two parallel groups (Fig. The study consisted of a 4-week prerecruitment (run-in) phase, followed by random assignment of participants to group A ( = 19).
The group A protocol included a 4-week probiotic treatment (one capsule every day for 4 weeks in addition to habitual diet), followed by a 4-week washout period and a 4-week placebo phase.