Abdominal Pain, Constipation, Diarrhea, Disbiosis, Stress
Conditions
Keywords
Lactoflorene plus, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus acidophilus, LA-5®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431®, Inflammation, gut permeability, disbiosis, probiotic, IgA, IL10
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactoflorene plus
2 vials with dosing cap (10 mL) a day per os
DIETARY_SUPPLEMENTPlacebo Lactoflorene plus
2 vials with dosing cap (10 mL) a day per os
Sponsors
Montefarmaco OTC SpA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.
Exclusion criteria
Most important
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NK activity | 45 days | Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group |
Secondary
| Measure | Time frame |
|---|---|
| microbiota composition investigation | 45 days |
| IgA, IL8, TNF-Alpha, IL10 | 45 days |
| Cortisol, alpha-amylase , chromogranin A | 45 days |
| Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation ) | 45 days |
Countries
Italy
Outcome results
None listed