NCT01564290

Brief Summary

The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

October 29, 2011

Last Update Submit

March 26, 2012

Conditions

Acute DiarrheaAcute Gastroenteritis

Keywords

acute diarrheaprobioticschildren

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhea

    participants will be followed for the duration of hospital stay, an expected average of 5 days

    five days

Secondary Outcomes (3)

  • Duration of fever

    five days

  • duration of vomiting

    five days

  • duration of hospitalization

    five days

Study Arms (2)

probiotic

PLACEBO COMPARATOR

Probiotic product with Sacharomices Boulardii

Drug: Placebo probiotic

probiotic yogurt

ACTIVE COMPARATOR

Yogurt with Lactobacilus Rhamnonsus strain spp

Dietary Supplement: Probiotic yogurt

Interventions

Probiotic yogurtDIETARY_SUPPLEMENT

Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

probiotic yogurt
Placebo probioticDRUG

Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.

Also known as: Florestor
probiotic

Eligibility Criteria

Age10 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All acute diarrhea

You may not qualify if:

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Pediatrico Albina Patino

Cochabamba, Departamento de Cochabamba, 0866, Bolivia

Location

Study Officials

  • Giuseppe E Grandy, MD MSc

    Centro Pediatrico Albina Patino

    PRINCIPAL INVESTIGATOR

  • Richard M Soria, MD

    Centro Pediatrico Albina Patino

    STUDY DIRECTOR

  • Sdenka Jose, MD

    Centro Pediatrico Albina Patino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research chief

Study Record Dates

First Submitted

October 29, 2011

First Posted

March 27, 2012

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

February 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations

BO(1)