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Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Primary Purpose

Diarrhea, Rotavirus Infection

Status
Completed
Phase
Not Applicable
Locations
Bolivia
Study Type
Interventional
Intervention
GB (Florestor)
GRALB
GC (placebo)
Sponsored by
Centro Pediatrico Albina de Patino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring acute diarrhea, rotavirus, probiotic, children

Eligibility Criteria

1 Month - 23 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Pediatrico Albina Patino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Duration of diarrhea

Secondary Outcome Measures

Duration of fever
Duration of vomiting
Duration of hospitalization

Full Information

First Posted
September 18, 2009
Last Updated
September 21, 2009
Sponsor
Centro Pediatrico Albina de Patino
Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
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1. Study Identification

Unique Protocol Identification Number
NCT00981877
Brief Title
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

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centro Pediatrico Albina de Patino
Collaborators
Instituto de Nutrición y Tecnología de los Alimentos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Rotavirus Infection
Keywords
acute diarrhea, rotavirus, probiotic, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
Arm Title
2
Arm Type
Active Comparator
Arm Description
This group will receive a mixed Probiotic preparation and oral rehydration as needed
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
This group will receive a placebo, and oral rehydration as needed
Intervention Type
Drug
Intervention Name(s)
GB (Florestor)
Other Intervention Name(s)
Florestor, Bioflora
Intervention Description
S. Boulardii preparation of 1 gram twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
GRALB
Other Intervention Name(s)
Probiotik, mixed probiotic
Intervention Description
mixed probiotic preparation 1 gram twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
GC (placebo)
Other Intervention Name(s)
Placebo
Intervention Description
Placebo 1 gram twice daily for 5 days.
Primary Outcome Measure Information:
Title
Duration of diarrhea
Time Frame
within the first 72 hours during hospitalization
Secondary Outcome Measure Information:
Title
Duration of fever
Time Frame
the first 72 hours during hospitalization
Title
Duration of vomiting
Time Frame
the first 72 hours during hospitalization
Title
Duration of hospitalization
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Soria, MD
Organizational Affiliation
Centro Pediatrico Albina Patino
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe E Grandy, Md
Organizational Affiliation
Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Pediatrico Albina Patino
City
Cochabamba
Country
Bolivia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22305197
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.
Results Reference
derived
PubMed Identifier
22272750
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.
Results Reference
derived
PubMed Identifier
22243622
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.
Results Reference
derived
PubMed Identifier
22225699
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.
Results Reference
derived
PubMed Identifier
22221511
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.
Results Reference
derived
PubMed Identifier
21658240
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.
Results Reference
derived
PubMed Identifier
20735858
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.
Results Reference
derived

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Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

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