Prospective Study to Determine the Factors Influencing Infant Colic

Infant Colic Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Colic
• Infant Colic

• NCT number: NCT05271747
• Study type: Interventional
• Source: AB Biotics, SA
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Completion date: December 30, 2023