Viral DiarrheaNCT05226052
Effect of the Use of Probiotic S. Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR.
A study testing Saccharomyces boulardii (Floratil 600mg) in people with Viral Diarrhea, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Diarrhea
- What is being tested?
- Saccharomyces boulardii (Floratil 600mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteMexico
- Study dates
- 21 Dec 2020to 3 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who give their informed consent,
- over 18 years of age,
- leukocytes in the stool,
- confirmed diagnosis of viral infection using the multiplex PCR
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Puerta de Hierro Sur
Tlajomulco de Zúñiga, Jalisco, 45640
About this study
Official title: Effect of the Use of Probiotic Saccharomyces Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR Technique, Randomized Clinical Trial (RCT).
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
Read the 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.
- Conditions
- Viral Diarrhea
- Being tested
- Saccharomyces boulardii (Floratil 600mg), 3 capsules of placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardii (Floratil 600mg)Dietary supplement
Also called PGIC and PGIS assessment
PGIC and PGIS assessment
3 capsules of placeboDietary supplement
Also called PGIC and PGIS assessment
PGIC and PGIS assessment
| Study group | Role | What they receive |
|---|---|---|
| S. boulardii | Experimental | treatment arm group (3 capsules of Floratil 200mg®/day) Receives: Dietary Supplement: Saccharomyces boulardii (Floratil 600mg) |
| Placebo | Placebo comparator | control group (3 capsules of placebo/day) Receives: Dietary Supplement: 3 capsules of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 8 days
Secondary outcomes (2)
Number of subjects with acute inflammatory viral diarrhea treated in the gastroenterology and coloproctology area
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.
Measured: 365 days
Number of subjects presenting associated symptoms in both groups in day 4 and 8 after diagnosis
To identify the incidence of associated symptoms, such as: fever and abdominal pain; assessed using the patient's daily record.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start21 Dec 2020
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Viral DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
- Investigators
- Alejandro Gonzalez Ojeda, MD, PhD, Study director, Instituto Mexica del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226052
- Sponsor's protocol ID
- 2020-PCR-SB
- Status last verified
- Sep 2023
- First submitted
- 14 Dec 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savola KL, Baron EJ, Tompkins LS, Passaro DJ. Fecal leukocyte stain has diagnostic value for outpatients but not inpatients. J Clin Microbiol. 2001 Jan;39(1):266-9. doi: 10.1128/JCM.39.1.266-269.2001.
PubMed 11136781Villarruel G, Rubio DM, Lopez F, Cintioni J, Gurevech R, Romero G, Vandenplas Y. Saccharomyces boulardii in acute childhood diarrhoea: a randomized, placebo-controlled study. Acta Paediatr. 2007 Apr;96(4):538-41. doi: 10.1111/j.1651-2227.2007.00191.x. Epub 2007 Feb 14.
PubMed 17306006Wang LP, Zhou SX, Wang X, Lu QB, Shi LS, Ren X, Zhang HY, Wang YF, Lin SH, Zhang CH, Geng MJ, Zhang XA, Li J, Zhao SW, Yi ZG, Chen X, Yang ZS, Meng L, Wang XH, Liu YL, Cui AL, Lai SJ, Liu MY, Zhu YL, Xu WB, Chen Y, Wu JG, Yuan ZH, Li MF, Huang LY, Li ZJ, Liu W, Fang LQ, Jing HQ, Hay SI, Gao GF, Yang WZ; Chinese Centers for Disease Control and Prevention (CDC) Etiology of Diarrhea Surveillance Study Team. Etiological, epidemiological, and clinical features of acute diarrhea in China. Nat Commun. 2021 Apr 29;12(1):2464. doi: 10.1038/s41467-021-22551-z.
PubMed 33927201Pang XL, Preiksaitis JK, Lee BE. Enhanced enteric virus detection in sporadic gastroenteritis using a multi-target real-time PCR panel: a one-year study. J Med Virol. 2014 Sep;86(9):1594-601. doi: 10.1002/jmv.23851. Epub 2013 Nov 14.
PubMed 24242161Chiejina M, Samant H. Viral Diarrhea. 2023 Sep 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470525/
PubMed 29262044Farfan M, Piemonte P, Labra Y, Henriquez J, Candia E, Torres JP. [Filmarray GI TM panel for detection of enteric pathogens in stool samples: preliminary experience]. Rev Chilena Infectol. 2016 Feb;33(1):89-91. doi: 10.4067/S0716-10182016000100016. Spanish.
PubMed 26965886Olaiz-Fernandez GA, Gomez-Pena EG, Juarez-Flores A, Vicuna-de Anda FJ, Morales-Rios JE, Carrasco OF. [Historical overview of acute infectious diarrhea in Mexico and future preventive strategies]. Salud Publica Mex. 2020 Jan-Feb;62(1):25-35. doi: 10.21149/10002. Spanish.
PubMed 31869558Palacio-Mejia LS, Rojas-Botero M, Molina-Velez D, Garcia-Morales C, Gonzalez-Gonzalez L, Salgado-Salgado AL, Hernandez-Avila JE, Hernandez-Avila M. Overview of acute diarrheal disease at the dawn of the 21st century: The case of Mexico. Salud Publica Mex. 2020 Jan-Feb;62(1):14-24. doi: 10.21149/9954.
PubMed 31314211Matthijnssens J, Otto PH, Ciarlet M, Desselberger U, Van Ranst M, Johne R. VP6-sequence-based cutoff values as a criterion for rotavirus species demarcation. Arch Virol. 2012 Jun;157(6):1177-82. doi: 10.1007/s00705-012-1273-3. Epub 2012 Mar 20.
PubMed 22430951Lanata CF, Fischer-Walker CL, Olascoaga AC, Torres CX, Aryee MJ, Black RE; Child Health Epidemiology Reference Group of the World Health Organization and UNICEF. Global causes of diarrheal disease mortality in children <5 years of age: a systematic review. PLoS One. 2013 Sep 4;8(9):e72788. doi: 10.1371/journal.pone.0072788. eCollection 2013.
PubMed 24023773Ahmed SM, Hall AJ, Robinson AE, Verhoef L, Premkumar P, Parashar UD, Koopmans M, Lopman BA. Global prevalence of norovirus in cases of gastroenteritis: a systematic review and meta-analysis. Lancet Infect Dis. 2014 Aug;14(8):725-730. doi: 10.1016/S1473-3099(14)70767-4. Epub 2014 Jun 26.
PubMed 24981041Sniffen JC, McFarland LV, Evans CT, Goldstein EJC. Choosing an appropriate probiotic product for your patient: An evidence-based practical guide. PLoS One. 2018 Dec 26;13(12):e0209205. doi: 10.1371/journal.pone.0209205. eCollection 2018.
PubMed 30586435Allen SJ, Martinez EG, Gregorio GV, Dans LF. Probiotics for treating acute infectious diarrhoea. Cochrane Database Syst Rev. 2010 Nov 10;2010(11):CD003048. doi: 10.1002/14651858.CD003048.pub3.
PubMed 21069673Salazar-Parra MA, Cruz-Neri RU, Trujillo-Trujillo XA, Dominguez-Mora JJ, Cruz-Neri HI, Guzman-Diaz JM, Guzman-Ruvalcaba MJ, Vega-Gastelum JO, Ascencio-Diaz KV, Zarate-Casas MF, Gonzalez-Ponce FY, Barbosa-Camacho FJ, Fuentes-Orozco C, Cervantes-Guevara G, Cervantes-Perez E, Cervantes-Cardona GA, Cortes-Flores AO, Gonzalez-Ojeda A. Effectiveness of Saccharomyces Boulardii CNCM I-745 probiotic in acute inflammatory viral diarrhoea in adults: results from a single-centre randomized trial. BMC Gastroenterol. 2023 Jul 3;23(1):229. doi: 10.1186/s12876-023-02863-8.
PubMed 37400812
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Probiotic Saccharomyces Boulardii on Acute Viral Inflammatory Diarrhea Diagnosed With Multiplex PCR Technique, Randomized Clinical Trial (RCT).
- ClinicalTrials.gov ID
- NCT05226052
- Acronym / sponsor ID
- 2020-PCR-SB
- Conditions
- Viral Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| S. boulardii | Experimental | Dietary Supplement: Saccharomyces boulardii (Floratil 600mg)treatment arm group (3 capsules of Floratil 200mg®/day) |
| Placebo | Placebo comparator | Dietary Supplement: 3 capsules of placebocontrol group (3 capsules of placebo/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who give their informed consent,
- over 18 years of age,
- leukocytes in the stool,
- confirmed diagnosis of viral infection using the multiplex PCR
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces boulardii (Floratil 600mg)Also: PGIC and PGIS assessmentPGIC and PGIS assessment | Dietary supplement | S. boulardii |
| 3 capsules of placeboAlso: PGIC and PGIS assessmentPGIC and PGIS assessment | Dietary supplement | Placebo |
Primary outcome
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.
2 secondary outcomes
Number of subjects with acute inflammatory viral diarrhea treated in the gastroenterology and coloproctology area
Time frame: 365 days
Number of subjects presenting associated symptoms in both groups in day 4 and 8 after diagnosis
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 11136781Savola KL, Baron EJ, Tompkins LS, Passaro DJ. Fecal leukocyte stain has diagnostic value for outpatients but not inpatients. J Clin Microbiol. 2001 Jan;39(1):266-9. doi: 10.1128/JCM.39.1.266-269.2001.
- Results publication: PubMed 17306006Villarruel G, Rubio DM, Lopez F, Cintioni J, Gurevech R, Romero G, Vandenplas Y. Saccharomyces boulardii in acute childhood diarrhoea: a randomized, placebo-controlled study. Acta Paediatr. 2007 Apr;96(4):538-41. doi: 10.1111/j.1651-2227.2007.00191.x. Epub 2007 Feb 14.
- Results publication: PubMed 33927201Wang LP, Zhou SX, Wang X, Lu QB, Shi LS, Ren X, Zhang HY, Wang YF, Lin SH, Zhang CH, Geng MJ, Zhang XA, Li J, Zhao SW, Yi ZG, Chen X, Yang ZS, Meng L, Wang XH, Liu YL, Cui AL, Lai SJ, Liu MY, Zhu YL, Xu WB, Chen Y, Wu JG, Yuan ZH, Li MF, Huang LY, Li ZJ, Liu W, Fang LQ, Jing HQ, Hay SI, Gao GF, Yang WZ; Chinese Centers for Disease Control and Prevention (CDC) Etiology of Diarrhea Surveillance Study Team. Etiological, epidemiological, and clinical features of acute diarrhea in China. Nat Commun. 2021 Apr 29;12(1):2464. doi: 10.1038/s41467-021-22551-z.
- Results publication: PubMed 24242161Pang XL, Preiksaitis JK, Lee BE. Enhanced enteric virus detection in sporadic gastroenteritis using a multi-target real-time PCR panel: a one-year study. J Med Virol. 2014 Sep;86(9):1594-601. doi: 10.1002/jmv.23851. Epub 2013 Nov 14.
- Results publication: PubMed 29262044Chiejina M, Samant H. Viral Diarrhea. 2023 Sep 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470525/
- Results publication: PubMed 26965886Farfan M, Piemonte P, Labra Y, Henriquez J, Candia E, Torres JP. [Filmarray GI TM panel for detection of enteric pathogens in stool samples: preliminary experience]. Rev Chilena Infectol. 2016 Feb;33(1):89-91. doi: 10.4067/S0716-10182016000100016. Spanish.
- Results publication: PubMed 31869558Olaiz-Fernandez GA, Gomez-Pena EG, Juarez-Flores A, Vicuna-de Anda FJ, Morales-Rios JE, Carrasco OF. [Historical overview of acute infectious diarrhea in Mexico and future preventive strategies]. Salud Publica Mex. 2020 Jan-Feb;62(1):25-35. doi: 10.21149/10002. Spanish.
- Results publication: PubMed 31314211Palacio-Mejia LS, Rojas-Botero M, Molina-Velez D, Garcia-Morales C, Gonzalez-Gonzalez L, Salgado-Salgado AL, Hernandez-Avila JE, Hernandez-Avila M. Overview of acute diarrheal disease at the dawn of the 21st century: The case of Mexico. Salud Publica Mex. 2020 Jan-Feb;62(1):14-24. doi: 10.21149/9954.
- Results publication: PubMed 22430951Matthijnssens J, Otto PH, Ciarlet M, Desselberger U, Van Ranst M, Johne R. VP6-sequence-based cutoff values as a criterion for rotavirus species demarcation. Arch Virol. 2012 Jun;157(6):1177-82. doi: 10.1007/s00705-012-1273-3. Epub 2012 Mar 20.
- Results publication: PubMed 24023773Lanata CF, Fischer-Walker CL, Olascoaga AC, Torres CX, Aryee MJ, Black RE; Child Health Epidemiology Reference Group of the World Health Organization and UNICEF. Global causes of diarrheal disease mortality in children <5 years of age: a systematic review. PLoS One. 2013 Sep 4;8(9):e72788. doi: 10.1371/journal.pone.0072788. eCollection 2013.
- Results publication: PubMed 24981041Ahmed SM, Hall AJ, Robinson AE, Verhoef L, Premkumar P, Parashar UD, Koopmans M, Lopman BA. Global prevalence of norovirus in cases of gastroenteritis: a systematic review and meta-analysis. Lancet Infect Dis. 2014 Aug;14(8):725-730. doi: 10.1016/S1473-3099(14)70767-4. Epub 2014 Jun 26.
- Results publication: PubMed 30586435Sniffen JC, McFarland LV, Evans CT, Goldstein EJC. Choosing an appropriate probiotic product for your patient: An evidence-based practical guide. PLoS One. 2018 Dec 26;13(12):e0209205. doi: 10.1371/journal.pone.0209205. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Gonzalez Ojeda, MD, PhD study director
Instituto Mexica del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces boulardii (Floratil 600mg) in people with Viral Diarrhea, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226052, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.