NCT02080130

Brief Summary

The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

March 4, 2014

Last Update Submit

September 4, 2018

Conditions

Gastroenteritis

Keywords

Gastroenteritisdiarrhea

Outcome Measures

Primary Outcomes (1)

  • Duration of diarrhoea in hours

    Up to 7 days

Secondary Outcomes (3)

  • Percentage of children requiring hospitalisation

    Up to 7 days

  • Adverse effects

    Up to 7 days

  • Number of liquid stools

    Up to seven days

Study Arms (3)

Saccharomyces boulardii

EXPERIMENTAL

FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.

Dietary Supplement: Saccharomyces boulardii

Probiotics combination

EXPERIMENTAL

LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu

Dietary Supplement: Probiotics combination

Placebo

PLACEBO COMPARATOR

Placebo sachet. One sachet orally, BID, for 5 days.

Other: Placebo

Interventions

Saccharomyces boulardiiDIETARY_SUPPLEMENT

FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.

Saccharomyces boulardii
Probiotics combinationDIETARY_SUPPLEMENT

LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu

Probiotics combination
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age1 Month - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of acute viral gastroenteritis

You may not qualify if:

  • Moderate or severe dehydration
  • Malnutrition
  • Immunodeficiencies
  • Sepsis or bacterial infection
  • Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
  • Hospitalisation
  • No phone number
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinaloa Pediatric Hospital

Culiacán, Sinaloa, 80200, Mexico

Location

MeSH Terms

Conditions

GastroenteritisDiarrhea

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Giordano Pérez-Gaxiola, MD

    Sinaloa Pediatric Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrician

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 6, 2014

Study Start

February 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations

ME(1)