Prospective Study to Determine the Factors Influencing Infant Colic

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    AB Biotics, SA
Updated on 7 February 2023
longum
Accepts healthy volunteers

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.

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.

Details
Condition Infant Colic
Treatment Lactoflora colicare, Reuteri gotas
Clinical Study IdentifierNCT05271747
SponsorAB Biotics, SA
Last Modified on7 February 2023

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