Lactobacillus Reuteri Versus Placebo in the Treatment and Prevention of Infantile Colic
Infantile Colic
About this trial
This is an interventional treatment trial for Infantile Colic focused on measuring infantile colic, lactobacillus, gut microflora, FISH, toll like receptor, T reg, messenger RNA, CC-chemokine receptor 7, interleukin 10
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- clinical evidence of chronic illness or gastrointestinal disorders
- administration of probiotics and antibiotics
Sites / Locations
- Ospedale Infantile Regina MargheritaRecruiting
- Ospedale Infantile Regina MargheritaRecruiting
- Ospedale Infantile Regina MargheritaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Lactobacillus reuteri
Placebo
L.reuteri + vit D
Vit D Placebo
Lactobacillus reuteri DSM 17938 is administered at a dose of 1.000.000.000 colony forming units (CFU) in V drops of a commercially available oil suspension, 30 min before feeding, once a day for 30 days.
Placebo is administered in V drops once a day for 30 days. Placebo is inactive, similar to the studied treatment with the same package, taste, characteristics of colour and consistency.
L. reuteri DSM 17938 (10^8 CFU) plus vitamin D3 (400 UI) five drops/day for 3 months
vitamin D3 (400 UI) five drops/day for 3 months