Effectiveness of Probiotic Supplementation on Crying Time in Infantile Colic
NCT ID: NCT03106285
Last Updated: 2022-05-05
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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WITHDRAWN
NA
INTERVENTIONAL
2017-04-14
2019-07-01
Brief Summary
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Detailed Description
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Lactobacillus reuteri has been shown in five studies to reduce crying time in infants diagnosed with infantile colic.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Lactobacillus reuteri DSM17938
Oil drops
Lactobacillus reuteri DSM17938
5 drops of active oil drops. The active dose consists of 10\^8 CFU L retueri DSM17938
Placebo
Oils drops
Placebo
5 drops of placebo drops
Interventions
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Lactobacillus reuteri DSM17938
5 drops of active oil drops. The active dose consists of 10\^8 CFU L retueri DSM17938
Placebo
5 drops of placebo drops
Eligibility Criteria
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Inclusion Criteria
* Infantile colic according to Roe IV criteria
* Full term infants
* Birth weight 2500 - 4000g
* Exclusively breast milk or partially breastfed
* Mothers last education degree is Senior high school
Exclusion Criteria
* Consumption of probiotics, antibiotics, PPI
* Failure to thrive
3 Months
ALL
No
Sponsors
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BioGaia AB
INDUSTRY
Responsible Party
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Principal Investigators
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Badriul Hegar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
RSCM, Rumah Sakit Cipto Mangunkusumo. University of Indonesia
Locations
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Badriul Hegar
Jakarta, , Indonesia
Countries
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Other Identifiers
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CSUB0130
Identifier Type: -
Identifier Source: org_study_id
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