Status:
WITHDRAWN
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
Lead Sponsor:
BioGaia AB
Collaborating Sponsors:
CRC CHI Creteil France
Association Clinique Thérapeutique Infantile du val de Marne
Conditions:
Infantile Colic
Eligibility:
All Genders
29-3 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged ...
Detailed Description
NOTE: The study never started.
Eligibility Criteria
Inclusion
- Exclusively breastfed Infants
- Infant aged of 29 days to 3 months
- With a diagnosis of infantile colic as defined by the Rome III criteria
- Birth at term and eutrophic (weight, height, head circumference)
- Apgar score\> 7 at 5 minutes
- Consent to the study signed by the two parents.
- Availability during the study period
Exclusion
- Associated severe chronic disease
- Acute infectious disease
- Personal or family first degree history of allergy to milk proteins
- Several infants of the same family from a multiple pregnancy
- Infants who received antibiotics one week prior to randomization
- Infants who received probiotics one week prior to randomization
- Mother who received antibiotics 1 week before randomization
- Regular consumption of probiotics by the mother 1 week before randomization
- Infants-included in another clinical study
- Lack of insurance coverage by the french social security
- Non exclusively breastfed infants
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01887444
Start Date
October 1 2013
End Date
September 1 2014
Last Update
February 4 2021
Active Locations (1)
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1
CRC CHIC and ACTIV
Créteil, France, 94010