Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

NCT00981877 | Completed

• 1 other identifier: protrota2007
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Rotavirus Infection

Keywords

acute diarrhea; rotavirus; probiotic; children

Outcome Measures

Primary Outcomes (1)

• Duration of diarrhea

  within the first 72 hours during hospitalization

Secondary Outcomes (3)

• Duration of fever

  the first 72 hours during hospitalization

• Duration of vomiting

  the first 72 hours during hospitalization

• Duration of hospitalization

  4 days

Study Arms (3)

1

ACTIVE COMPARATOR

This group will receive S. Boulardii Probiotic and Oral rehydration as needed

Drug: GB (Florestor)

2

ACTIVE COMPARATOR

This group will receive a mixed Probiotic preparation and oral rehydration as needed

Drug: GRALB

3

PLACEBO COMPARATOR

This group will receive a placebo, and oral rehydration as needed

Drug: GC (placebo)

Interventions

GB (Florestor) DRUG

S. Boulardii preparation of 1 gram twice daily for 5 days

Also known as: Florestor, Bioflora

1

GRALB DRUG

mixed probiotic preparation 1 gram twice daily for 5 days.

Also known as: Probiotik, mixed probiotic

2

GC (placebo) DRUG

Placebo 1 gram twice daily for 5 days.

Also known as: Placebo

3

Eligibility Criteria

• Age: 1 Month - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Positive stool sample for rotavirus test

You may not qualify if:

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

Sponsors & Collaborators

• Centro Pediatrico Albina de Patino: lead
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator

Study Sites (1)

Centro Pediatrico Albina Patino

Cochabamba, Departamento de Cochabamba, Bolivia

Location

Related Publications (7)

• 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.

  PMID: 22305197 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.

  PMID: 22272750 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.

  PMID: 22243622 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.

  PMID: 22225699 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.

  PMID: 22221511 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.

  PMID: 21658240 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.

  PMID: 20735858 DERIVED

MeSH Terms

Conditions

Diarrhea; Rotavirus Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: July 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 22, 2009

Record last verified: 2009-09

Locations

BO (1)