Status:
COMPLETED
Infant Colic Treatment With Probiotics
Lead Sponsor:
Mónica Olivares Martín; PhD
Collaborating Sponsors:
European Regional Development Fund
Ministerio de Ciencia e Innovación, Spain
Conditions:
Infant Colic
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
Brief Summary
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve C...
Detailed Description
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fer...
Eligibility Criteria
Inclusion
- Infants from 3 to 12 weeks of age
- 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
- Failure to thrive
- 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
Key Trial Info
Start Date :
May 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03467334
Start Date
May 31 2017
End Date
June 15 2019
Last Update
July 23 2019
Active Locations (1)
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1
Servicio Andaluz de Salud
Granada, Spain, 10012