Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.

Conditions
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Disbiosis, Abdominal Pain, Constipation, Diarrhea, Stress

Intervention / Treatment
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* Dietary Supplement: Lactoflorene plus
* Dietary Supplement: Placebo Lactoflorene plus


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoflorene plus<br>10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day | Dietary Supplement: Lactoflorene plus<br>* 2 vials with dosing cap (10 mL) a day per os<br>|
| Placebo Comparator: Placebo Lactoflorene plus<br>Identical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling. | Dietary Supplement: Placebo Lactoflorene plus<br>* 2 vials with dosing cap (10 mL) a day per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK activity | Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgA, IL8, TNF-Alpha, IL10 |  | 45 days | 
| Cortisol, alpha-amylase , chromogranin A |  | 45 days | 
| microbiota composition investigation |  | 45 days | 
| Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation ) |  | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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