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

NCT03234452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-09-09

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactoflorene plus

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

DIETARY_SUPPLEMENT

Placebo Lactoflorene plus

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

Sponsors & Collaborators

  • Montefarmaco OTC SpA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-23
Primary Completion
2016-07-21
Completion
2017-04-18

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234452 on ClinicalTrials.gov