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Prevention of Antibiotic-Associated Diarrhoea With Prolardii

NCT03256708 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-04-03

No results posted yet for this study

Summary

Prolardii contains intestinal bacteria, a yeast, a fructo-oligosaccharide and a plant extract that can contribute to the intestinal comfort. This product could prevent the diarrhea which sometimes occurs when the patient has to take antibiotics.

A total of 220 patients being prescribed antibiotics by general practitioners will be included in the study and randomized into a Prolardii arm and a placebo arm.

The primary endpoint will be the overall frequency of diarrhea in the two treatment groups. Acute diarrhea will be defined as the presence of three or more abnormally loose or watery stools per day.

Conditions

  • Antibiotic-associated Diarrhea

Interventions

DIETARY_SUPPLEMENT

Prolardii

Prolardii: 2 capsules per day for 12 to 15 days

DIETARY_SUPPLEMENT

Placebo

Inactive ingredients

Sponsors & Collaborators

  • ECSOR

    collaborator UNKNOWN

  • Therabel Pharma SA/NV

    lead INDUSTRY

Principal Investigators

  • Nicolas Foucart · Marketing Manager

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-19
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Belgium

Study Locations

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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 NCT03256708 on ClinicalTrials.gov