Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of the Use of Probiotic S. Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226052
Recruitment Status : Completed
First Posted : February 7, 2022
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Brief 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

Condition or disease Intervention/treatment Phase
Viral Diarrhea Dietary Supplement: Saccharomyces boulardii (Floratil 600mg) Dietary Supplement: 3 capsules of placebo Not Applicable

Detailed Description:

Acute diarrhea (AD) has been a public health problem throughout the history of Mexico. According to the epidemiological surveillance system, between 2008 and 2017, five to six million new cases of AD occurred per year. The 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 Polymerase Chain Reaction (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 wll 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 Patient Global Impression scale of Severity (PGIS) are 1-item questionnaire that ask an individual patient to rate the severity of a specific condition (single-state scales) at baseline and or to rate at endpoint the perceived change in his/her condition in response to therapy; in the other hand The Patient Global Impression scale of Change (PGIC) measures change in clinical status.

Research question: What is the effect of the use of probiotic S. boulardii on acute inflammatory diarrhea of viral etiology diagnosed with multiplex PCR technique? Hypothesis: The use of S. boulardii in patients with acute viral inflammatory diarrhea diagnosed with the Multiplex PCR technique will decrease the days of associated symptoms and self-reported improvement.

Main objective: To analyze the effect of the use of S. boulardii on acute inflammatory viral diarrhea diagnosed with the Multiplex PCR technique.

Specifics: 1. To determine the incidence of viral pathogens in patients diagnosed with acute inflammatory viral diarrhea treated in the gastroenterology and coloproctology area. 2. To identify the incidence of associated symptoms in both groups in day 4 and 8 after diagnosis. 3. Compare the days of self-reported improvement by the patient between both groups using the PGIS and PGIC surveys.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: : The person delegated to assigns treatment is the nurse of the medical office. Assignment will be done using a simple excel algorithm. The cans are numbered sequentially. The blindness will be broken until the statistical analysis is completed
Primary Purpose: Treatment
Official Title: Effect of the Use of Probiotic Saccharomyces Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR Technique, Randomized Clinical Trial (RCT).
Actual Study Start Date : December 21, 2020
Actual Primary Completion Date : January 3, 2022
Actual Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: S. boulardii
treatment arm group (3 capsules of Floratil 200mg®/day)
Dietary Supplement: Saccharomyces boulardii (Floratil 600mg)
PGIC and PGIS assessment
Other Name: PGIC and PGIS assessment

Placebo Comparator: Placebo
control group (3 capsules of placebo/day)
Dietary Supplement: 3 capsules of placebo
PGIC and PGIS assessment
Other Name: PGIC and PGIS assessment




Primary Outcome Measures :
  1. Number of subjects with S. boulardii on acute inflammatory viral diarrhea diagnosed with Multiplex PCR technique as treatment that have a change in the severity of their symptoms measured with PGIS and PGIC assessments at day 4 and day 8. [ Time Frame: 8 days ]
    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 (single-state scales) 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.


Secondary Outcome Measures :
  1. Number of subjects with acute inflammatory viral diarrhea treated in the gastroenterology and coloproctology area [ Time Frame: 12 months ]
    To determine the incidence of viral pathogens in patients diagnosed with acute inflammatory viral diarrhea treated in the gastroenterology and coloproctology area during the 12 month period; measured by applying the multiplex PCR test to determine the causative pathogen.

  2. Number of subjects presenting associated symptoms in both groups in day 4 and 8 after diagnosis [ Time Frame: 8 days ]
    To identify the incidence of associated symptoms, such as: fever and abdominal pain; assessed using the patient's daily record.


Other Outcome Measures:
  1. Compare the days of self-reported improvement by the patient between both groups using the PGIS and PGIC surveys. [ Time Frame: 8 days ]
    Compare the days of self-reported improvement by the patient between both groups using the PGIS and PGIC surveys.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who give their informed consent,
  • over 18 years of age,
  • leukocytes in the stool,
  • confirmed diagnosis of viral infection using the multiplex PCR

Exclusion Criteria:

  • Confirmed diagnosis of infection by bacteria and/or parasites, associated or not with viral etiology;
  • autoimmune diseases or immunosuppressive treatment;
  • previous administration of antibiotic treatment during the last 7 days;
  • consumption of any type of probiotic in the last 7 days;
  • known allergy to probiotic containing S. boulardii;
  • Inflammatory Bowel Disease;
  • positive test or clinical positivity to the current operational definition for severe acute respiratory syndrome coronavirus 2 (SARS-COV-2).
  • patients who do not have medical insurance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226052


Locations
Layout table for location information
Mexico
Hospital Puerta de Hierro Sur
Tlajomulco De Zúñiga, Jalisco, Mexico, 45640
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Layout table for investigator information
Study Director: Alejandro Gonzalez Ojeda, MD, PhD Instituto Mexica del Seguro Social
Publications of Results:

Layout table for additonal information
Responsible Party: GONZALEZ-OJEDA ALEJANDRO, Clinical Professor, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT05226052    
Other Study ID Numbers: 2020-PCR-SB
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive