CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Saccharomyces boulardii (Floratil 600mg) +1 moredietary
Likely dose
Saccharomyces boulardii (Floratil 600mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05226052
NCT05226052N/ACompleted

Effect of the Use of Probiotic Saccharomyces Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR Technique, Randomized Clinical Trial (RCT).

Instituto Mexicano del Seguro Social·interventional·Posted Feb 7, 2022·Updated Oct 3, 2023

In Brief

A clinical study evaluating Saccharomyces boulardii (Floratil 600mg) and 3 capsules of placebo for Viral Diarrhea. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Acute diarrhea (AD) has been a public health problem throughout the history of Mexico. According to the epidemiological surveillance system, between 2008-2017, five to six million new cases of AD occurred per year. Clinical presentation of viral gastroenteritis ranges from an asymptomatic state to diarrhea with severe dehydration. Viral etiology can be difficult to differentiate from those of gastroenteritis caused by enteric bacteria based solely on clinical presentation, especially due to the presence of leukocytes in stool, since it was thought that only diarrhea of bacterial etiology was present and what defines it as acute inflammatory diarrhea; therefore, laboratory studies are essential to make a specific diagnosis. In addition to methylene blue test traditionally performed to describe the presence of leukocytes in stool, multiplex PCR is an automated system in which the extraction, amplification and detection of nucleic acid occurs in a single closed pouch. The panel includes for the etiological identification of bacteria, parasites and viruses. Probiotics are effective for acute infectious diarrhea caused by bacteria, but there are inconsistent results on the effectiveness of probiotics for diarrhea caused by viruses. It is important to note that there are no studies in the adult population with acute diarrhea of viral etiology identified by PCR Multiplex in our environment and the use of probiotics to reduce the period of convalescence. Mexico also lacks for detection tests to identify the pathogen, that can be used routinely in clinical practice, as other countries has shown the economical, clinical outcomes and patient satisfaction results with it. In a review, S. boulardii shows an effectiveness in 4 of the 6 studies where it was used as a treatment in acute adult viral diarrhea, where it was used as a treatment. Based on this review, because it considers the adult population, it will be used S. boulardii as a treatment in patients diagnosed with acute viral diarrhea, to reduce the days of presence of associated symptoms. The Patient Global Impression scale (PGI) is the Patient-reported outcomes counterpart to the Clinical Global Impressions scale. The PGIS are 1-item questionnaire that ask an individual patient to rate the severity of a specific condition at baseline and or to rate at endpoint the perceived change in his/her condition in response to therapy; in the other hand PGIC measures change in clinical status

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsViral Diarrhea
CountriesMexico
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 7, 2022
Enrollment StartDec 21, 2020
Primary CompletionJan 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.4 years ago

Interventions

Saccharomyces boulardii (Floratil 600mg)dietary

PGIC and PGIS assessment

3 capsules of placebodietary

PGIC and PGIS assessment