Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
NCT ID: NCT01067027
Last Updated: 2011-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2009-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Interventions
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Lactobacillus reuteri
5 drops of study product 30 minutes before feeding.
Eligibility Criteria
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Inclusion Criteria
* Breast fed, exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
* Debut of colic symptoms 6+/-1 days before randomization
* Gestational age between 37 and 42 weeks
* Apgar score higher than 7 at 5 minutes
* Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
* Written informed consent from one or both parents
* Stated availability throughout the study period
Exclusion Criteria
* Administration of anitbiotics the week before randomization
* Administration of probiotics the week before randomization
* Participation in other clinical trials
14 Days
60 Days
ALL
Yes
Sponsors
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Children's Investigational Research Program, LLC
OTHER
Responsible Party
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Children's Investigational Research Program
Principal Investigators
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Bryan M Harvey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Investigational Research Program
Locations
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Children's Investigational Research Program
Bentonville, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Colic001
Identifier Type: -
Identifier Source: org_study_id
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