NCT01273012

Brief Summary

The purpose of this study is to determine whether the probiotic Infloran is cost-effective in treating acute childhood diarrhea.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 1, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

January 3, 2011

Last Update Submit

July 28, 2011

Conditions

Acute Diarrhea

Keywords

probioticcost-effectivenessdiarrheachildrenSum of the monetary cost of the hospitalization

Outcome Measures

Primary Outcomes (1)

  • monetary cost of hospitalization in Thai Baht

    from admission to discharge date, approximately 1-7 days

Secondary Outcomes (1)

  • days of hospitalization

    from admission to discharge date, approximately 1-7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The group of patients treated with placebo.

Drug: Probiotic - Infloran

Infloran

EXPERIMENTAL

The group of patients treated with Infloran.

Drug: Probiotic - Infloran

Interventions

Probiotic - InfloranDRUG

Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid

Also known as: Infloran, L. acidophilus, B. bifidum
InfloranPlacebo

Eligibility Criteria

Age3 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 3 months to 6 years of age
  • Hospitalized due to acute diarrhea

You may not qualify if:

  • History of probiotic treatment in this episode of illness
  • History of use of other anti-diarrheal medications
  • Chronic gastrointestinal disease(s)
  • Severe dehydration
  • Severe systemic disease(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Phramongkutklao Hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Diarrhea

Interventions

acidocin D20079, Lactobacillus acidophilus

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nopaorn Phavichitr, MD

    Department of Pediatrics, Phramongkutklao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 10, 2011

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

August 1, 2011

Record last verified: 2011-07

Locations

TH(1)