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Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Giordano Perez Gaxiola, Sinaloa Pediatric Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02080130
First Posted: March 6, 2014
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giordano Perez Gaxiola, Sinaloa Pediatric Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Giordano Perez Gaxiola, Sinaloa Pediatric Hospital:

Primary Outcome Measures:
  • Duration of diarrhoea in hours [ Time Frame: Up to 7 days ]

Secondary Outcome Measures:
  • Percentage of children requiring hospitalisation [ Time Frame: Up to 7 days ]
  • Adverse effects [ Time Frame: Up to 7 days ]
  • Number of liquid stools [ Time Frame: Up to seven days ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Giordano Perez Gaxiola, Pediatrician, Sinaloa Pediatric Hospital
ClinicalTrials.gov Identifier: NCT02080130     History of Changes
Other Study ID Numbers: HPS-03
First Submitted: March 4, 2014
First Posted: March 6, 2014
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Giordano Perez Gaxiola, Sinaloa Pediatric Hospital:
Gastroenteritis
diarrhea

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