Prospective Study to Determine the Factors Influencing Infant Colic (NCT05271747) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study to Determine the Factors Influencing Infant Colic
Mexico, Spain112 participantsStarted 2019-03-01
Plain-language summary
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.
Who can participate
Age range2 Weeks – 12 Weeks
SexALL
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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.