Clinical trial NCT00981877: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
Official title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Rotavirus Infection
Keywords: acute diarrhea
rotavirus
probiotic
children
Lead sponsor: Centro Pediatrico Albina de Patino
Sponsor class: OTHER
Collaborators: name: Instituto de Nutrición y Tecnología de los Alimentos
First posted: 2009-09-22
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Positive stool sample for rotavirus test

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
* Systemic infections
* Severe chronic disease
* Mixed enteric infections besides rotavirus

Primary outcomes:
measure: Duration of diarrhea
timeFrame: within the first 72 hours during hospitalization
Secondary outcomes:
measure: Duration of fever
timeFrame: the first 72 hours during hospitalization
measure: Duration of vomiting
timeFrame: the first 72 hours during hospitalization
measure: Duration of hospitalization
timeFrame: 4 days
Other outcomes:
Locations:
city: Cochabamba
country: Bolivia
facility: Centro Pediatrico Albina Patino
Study officials:
affiliation: Centro Pediatrico Albina Patino
name: Richard M Soria, MD
role: STUDY_DIRECTOR
affiliation: Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
name: Giuseppe E Grandy, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.