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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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2017-05-31
2019-06-15
Brief Summary
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Detailed Description
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The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone.
It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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B. breve
Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.
B. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day
B. breve plus L. fermentum
Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.
B. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day
Simethicone 20 mg
Control group that will receive simethicone 4 times (10 drops) a day.
Simethicone 20 MG
Standard treatment for infant colic
Interventions
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B. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day
B. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day
Simethicone 20 MG
Standard treatment for infant colic
Eligibility Criteria
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Inclusion Criteria
* Born at least at week 34
* Birth weight equal to or greater than 2000 grams
* Fulfill the criteria of Rome III
* Informed consent signed by parents or guardians
Exclusion Criteria
* Antibiotic treatment less than 2 weeks before the study or during the study
* Take probiotics as a treatment, different from the one that could contain the powdered infant formula
* Abandon breastfeeding and switch to infant formula
* Failure to comply with the study protocol
3 Weeks
12 Weeks
ALL
No
Sponsors
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European Regional Development Fund
OTHER
Ministerio de Ciencia e Innovación, Spain
OTHER_GOV
Mónica Olivares Martín; PhD
INDUSTRY
Responsible Party
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Mónica Olivares Martín; PhD
Head of the R & D Department
Principal Investigators
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José Maldonado, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)
Locations
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Servicio Andaluz de Salud
Granada, , Spain
Countries
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Other Identifiers
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P040
Identifier Type: -
Identifier Source: org_study_id
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