A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
2 vials with dosing cap (10 mL) a day per os
2 vials with dosing cap (10 mL) a day per os
Centro Ricerche Cliniche di Verona Srl,
Verona, (Vr), Italy
NK activity
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
Time frame: 45 days
IgA, IL8, TNF-Alpha, IL10
Time frame: 45 days
Cortisol, alpha-amylase , chromogranin A
Time frame: 45 days
microbiota composition investigation
Time frame: 45 days
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
Time frame: 45 days
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