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| Name | Class |
|---|---|
| Instituto de Nutrición y TecnologÃa de los Alimentos | OTHER |
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The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.
Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | This group will receive S. Boulardii Probiotic and Oral rehydration as needed |
|
| 2 | Active Comparator | This group will receive a mixed Probiotic preparation and oral rehydration as needed |
|
| 3 | Placebo Comparator | This group will receive a placebo, and oral rehydration as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB (Florestor) | Drug | S. Boulardii preparation of 1 gram twice daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhea | within the first 72 hours during hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of fever | the first 72 hours during hospitalization | |
| Duration of vomiting | the first 72 hours during hospitalization | |
| Duration of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Soria, MD | Centro Pediatrico Albina Patino | Study Director |
| Giuseppe E Grandy, Md | Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Pediatrico Albina Patino | Cochabamba | Cochabamba | Bolivia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305197 | Derived | Smithline HA, Donnino M, Greenblatt DJ. Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects. BMC Clin Pharmacol. 2012 Feb 4;12:4. doi: 10.1186/1472-6904-12-4. | |
| 22272750 | Derived | Waldvogel S, Pedrazzini B, Vaucher P, Bize R, Cornuz J, Tissot JD, Favrat B. Clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors: a randomized controlled trial. BMC Med. 2012 Jan 24;10:8. doi: 10.1186/1741-7015-10-8. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012088 | Reoviridae Infections |
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| GRALB | Drug | mixed probiotic preparation 1 gram twice daily for 5 days. |
|
|
| GC (placebo) | Drug | Placebo 1 gram twice daily for 5 days. |
|
|
| 4 days |
| 22243622 | Derived | Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10. |
| 22225699 | Derived | Wiseman V, Mangham LJ, Cundill B, Achonduh OA, Nji AM, Njei AN, Chandler C, Mbacham WF. A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial. Trials. 2012 Jan 6;13:4. doi: 10.1186/1745-6215-13-4. |
| 22221511 | Derived | Husebye EE, Lyberg T, Opdahl H, Aspelin T, Stoen RO, Madsen JE, Roise O. Intramedullary nailing of femoral shaft fractures in polytraumatized patients. a longitudinal, prospective and observational study of the procedure-related impact on cardiopulmonary- and inflammatory responses. Scand J Trauma Resusc Emerg Med. 2012 Jan 5;20:2. doi: 10.1186/1757-7241-20-2. |
| 21658240 | Derived | Pontes-Arruda A, Martins LF, de Lima SM, Isola AM, Toledo D, Rezende E, Maia M, Magnan GB; Investigating Nutritional Therapy with EPA, GLA and Antioxidants Role in Sepsis Treatment (INTERSEPT) Study Group. Enteral nutrition with eicosapentaenoic acid, gamma-linolenic acid and antioxidants in the early treatment of sepsis: results from a multicenter, prospective, randomized, double-blinded, controlled study: the INTERSEPT study. Crit Care. 2011 Jun 9;15(3):R144. doi: 10.1186/cc10267. |
| 20735858 | Derived | Grandy G, Medina M, Soria R, Teran CG, Araya M. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children. BMC Infect Dis. 2010 Aug 25;10:253. doi: 10.1186/1471-2334-10-253. |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |