Status:
UNKNOWN
Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic
Lead Sponsor:
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Conditions:
Infantile Colic
Eligibility:
All Genders
4-16 years
Phase:
NA
Brief Summary
The purpose of this study is: * to study the intestinal microflora of colicky infants before and after L. reuteri or placebo administration, evaluating the effect of Lactobacillus reuteri on the grow...
Detailed Description
Infantile colic is one of the most common problems within the first three months of life. It consists of a behavioural syndrome characterised by paroxysmal, excessive and inconsolable crying without i...
Eligibility Criteria
Inclusion
- clinical diagnosis of infantile colic according to Wessel's criteria
- gestational age between 37 and 42 weeks
- age between 4 and 16 weeks
- birth weight between 2500 and 4000 g
- exclusively breastfed
Exclusion
- clinical evidence of chronic illness or gastrointestinal disorders
- administration of probiotics and antibiotics
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00893711
Start Date
March 1 2008
End Date
December 1 2022
Last Update
March 3 2021
Active Locations (3)
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1
Ospedale Infantile Regina Margherita
Torino, TO, Italy, 10126
2
Ospedale Infantile Regina Margherita
Torino, Italy, 10126
3
Ospedale Infantile Regina Margherita
Torino, Italy, 10126