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Prospective Study to Determine the Factors Influencing Infant Colic | Clinical Trials | Clareo Health

COMPLETEDNA

Prospective Study to Determine the Factors Influencing Infant Colic

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

NCT05271747•AB Biotics, SA

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.

Detailed 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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (4)

Hospital Medica Sur, room 108, tower 2

Mexico City, Mexico

University Hospital Santa Lucía

Cartagena, Murcia, Spain

HM Hospitals

Barcelona, Spain

Hm Hospitals

Madrid, Spain

Key Dates

Start Date

March 1, 2019

Primary Completion Date

December 30, 2023

Completion Date

December 30, 2023

Last Updated

February 24, 2026

Enrollment

112

ACTUAL participants

Conditions

Infant Colic

Interventions

AB-Kolicare

DIETARY_SUPPLEMENT

Reuteri gotas

DIETARY_SUPPLEMENT

Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein

NCT04015089

Infant Colic

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COMPLETEDNA

Lactocare Baby Drops in Infants Colic

NCT02839239

Infant Colic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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