Prospective Study to Determine the Factors Influencing Infant Colic

Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics

Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.

Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).

Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.

Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.

Inclusion Criteria:

• Healthy infants from 2 to 12 weeks of age
• Infants diagnosed with infant colic following Roma IV criteria for clinical research
• Gestational age greater or equal to 37 weeks
• Birth weight greater than 2100 g
• Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.

Exclusion Criteria:

• Infants that are fed with solid food.
• Infants whose parents can not appropriately follow the requirements of the study.
• Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
• Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
• Infants fed extensively hydrolyzed infant formula
• Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
• Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.