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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-23

Study Completion Date

2017-04-18

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.

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Detailed Description

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Conditions

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Disbiosis Abdominal Pain Constipation Diarrhea Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized, double-blind, placebo-controlled, cross-over trial performed at one centre

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double-blind

Study Groups

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Lactoflorene plus

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

Group Type EXPERIMENTAL

Lactoflorene plus

Intervention Type DIETARY_SUPPLEMENT

2 vials with dosing cap (10 mL) a day per os

Placebo Lactoflorene plus

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.

Group Type PLACEBO_COMPARATOR

Placebo Lactoflorene plus

Intervention Type DIETARY_SUPPLEMENT

2 vials with dosing cap (10 mL) a day per os

Interventions

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Lactoflorene plus

2 vials with dosing cap (10 mL) a day per os

Intervention Type DIETARY_SUPPLEMENT

Placebo Lactoflorene plus

2 vials with dosing cap (10 mL) a day per os

Intervention Type DIETARY_SUPPLEMENT

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes