Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Sinaloa Pediatric Hospital
Sponsor:
Information provided by (Responsible Party):
Giordano Perez Gaxiola, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier:
NCT02080130
First received: March 4, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Dietary Supplement: Saccharomyces boulardii
Dietary Supplement: Probiotics combination
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sinaloa Pediatric Hospital:

Primary Outcome Measures:
  • Duration of diarrhoea in hours [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of children requiring hospitalisation [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: Up to 7 days ] [ Designated as safety issue: Yes ]
  • Number of liquid stools [ Time Frame: Up to seven days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Dietary Supplement: Saccharomyces boulardii
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Experimental: Probiotics combination
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
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
Placebo Comparator: Placebo
Placebo sachet. One sachet orally, BID, for 5 days.
Other: Placebo
Placebo

Detailed Description:

Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute viral gastroenteritis

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080130

Contacts
Contact: Giordano Pérez-Gaxiola, MD +52 (667) 7139004 ext 252 giordano@sinestetoscopio.com

Locations
Mexico
Sinaloa Pediatric Hospital Recruiting
Culiacan, Sinaloa, Mexico, 80200
Contact: Giordano Pérez-Gaxiola, MD    +52 (667) 7139004 ext 252    giordano@sinestetoscopio.com   
Principal Investigator: Giordano Pérez-Gaxiola, MD         
Sponsors and Collaborators
Sinaloa Pediatric Hospital
Investigators
Study Chair: Giordano Pérez-Gaxiola, MD Sinaloa Pediatric Hospital
  More Information

No publications provided

Responsible Party: Giordano Perez Gaxiola, Pediatrician, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier: NCT02080130     History of Changes
Other Study ID Numbers: HPS-03
Study First Received: March 4, 2014
Last Updated: March 5, 2014
Health Authority: Mexico: Secretaria de Salud

Keywords provided by Sinaloa Pediatric Hospital:
Gastroenteritis
diarrhea

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014