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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S. boulardii | Experimental | treatment arm group (3 capsules of Floratil 200mg®/day) |
|
| Placebo | Placebo Comparator | control group (3 capsules of placebo/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii (Floratil 600mg) | Dietary Supplement | PGIC and PGIS assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the days of self-reported improvement by the patient between both groups using the PGIS and PGIC surveys. | Compare the days of self-reported improvement by the patient between both groups using the PGIS and PGIC surveys. | 8 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Gonzalez Ojeda, MD, PhD | Instituto Mexica del Seguro Social | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Puerta de Hierro Sur | Tlajomulco de Zúñiga | Jalisco | 45640 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11136781 | Result | 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. | |
| 17306006 | Result | Villarruel 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. |
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Randomized, double-blind clinical trial
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: 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
| 3 capsules of placebo | Dietary Supplement | PGIC and PGIS assessment |
|
|
| 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. | 8 days |
| 33927201 | Result | Wang 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. |
| 24242161 | Result | Pang 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. |
| 29262044 | Result | Chiejina 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/ |
| 26965886 | Result | Farfan 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. |
| 31869558 | Result | Olaiz-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. |
| 31314211 | Result | Palacio-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. |
| 22430951 | Result | Matthijnssens 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. |
| 24023773 | Result | Lanata 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. |
| 24981041 | Result | Ahmed 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. |
| 30586435 | Result | Sniffen 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. |
| 21069673 | Result | Allen 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. |
| 37400812 | Derived | Salazar-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. |