Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children - Full Text View

Purpose

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.

Condition	Intervention
Diarrhea Rotavirus Infection	Drug: GB (Florestor) Drug: GRALB Drug: GC (placebo)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Rotavirus Infections

U.S. FDA Resources

Further study details as provided by Centro Pediatrico Albina de Patino:

Primary Outcome Measures:

Duration of diarrhea [ Time Frame: within the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration of fever [ Time Frame: the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]
Duration of vomiting [ Time Frame: the first 72 hours during hospitalization ] [ Designated as safety issue: Yes ]
Duration of hospitalization [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment:	76
Study Start Date:	July 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 This group will receive S. Boulardii Probiotic and Oral rehydration as needed	Drug: GB (Florestor) S. Boulardii preparation of 1 gram twice daily for 5 days Other Name: Florestor, Bioflora
Active Comparator: 2 This group will receive a mixed Probiotic preparation and oral rehydration as needed	Drug: GRALB mixed probiotic preparation 1 gram twice daily for 5 days. Other Name: Probiotik, mixed probiotic
Placebo Comparator: 3 This group will receive a placebo, and oral rehydration as needed	Drug: GC (placebo) Placebo 1 gram twice daily for 5 days. Other Name: Placebo

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

Ages Eligible for Study:	1 Month to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981877

Locations

Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia

Sponsors and Collaborators

Centro Pediatrico Albina de Patino

Instituto de Nutricion y Tecnologia de los Alimentos

Investigators

Study Director:	Richard M Soria, MD	Centro Pediatrico Albina Patino
Principal Investigator:	Giuseppe E Grandy, Md	Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos

More Information

No publications provided by Centro Pediatrico Albina de Patino

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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, Teirilä 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.

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.

Husebye EE, Lyberg T, Opdahl H, Aspelin T, Støen RO, Madsen JE, Røise 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.

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, ?-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.

Grandy G, Medina M, Soria R, Terán 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.

Responsible Party:	Giuseppe Grandy Aranda, Centro Pediatrico Albina de Patino/ Departamento de Gastroenterologia y Nutricion
ClinicalTrials.gov Identifier:	NCT00981877 History of Changes
Other Study ID Numbers:	protrota2007
Study First Received:	September 18, 2009
Last Updated:	September 21, 2009
Health Authority:	Bolivia: Ministry of Health

Keywords provided by Centro Pediatrico Albina de Patino:

acute diarrhea
rotavirus
probiotic
children

Additional relevant MeSH terms:

Diarrhea
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms

Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013