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Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients

NCT06283784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-18

No results posted yet for this study

Summary

This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.

The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days)

Conditions

Interventions

OTHER

Yovis Capsules

Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

OTHER

Placebo

Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Sponsors & Collaborators

  • Hippocrates Research

    collaborator OTHER

  • Biofarma

    lead INDUSTRY

Principal Investigators

  • Riccardo Agati, MD · General Practitioner

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-05
Primary Completion
2021-11-02
Completion
2022-05-18

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 NCT06283784 on ClinicalTrials.gov