Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02080130 |
Date of registration:
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04/03/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
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Scientific title:
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Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial |
Date of first enrolment:
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February 2014 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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https://clinicaltrials.gov/show/NCT02080130 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Giordano PĂ©rez-Gaxiola, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Sinaloa Pediatric Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Month
Age maximum:
5 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroenteritis
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Intervention(s)
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Dietary Supplement: Probiotics combination
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Other: Placebo
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Dietary Supplement: Saccharomyces boulardii
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Primary Outcome(s)
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Duration of diarrhoea in hours
[Time Frame: Up to 7 days]
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Secondary Outcome(s)
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Percentage of children requiring hospitalisation
[Time Frame: Up to 7 days]
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Number of liquid stools
[Time Frame: Up to seven days]
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Adverse effects
[Time Frame: Up to 7 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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