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.

Study Overview

• Status: Completed
• Conditions: Infant Colic
• Intervention / Treatment: Dietary supplement: Reuteri gotas; Dietary supplement: AB-Kolicare

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14050
    • Hospital Medica Sur, room 108, tower 2
• Spain
  • Barcelona, Spain
    • Hm Hospitals
  • Madrid, Spain
    • Hm Hospitals
  • Murcia
    • Cartagena, Murcia, Spain, 30202
      • University Hospital Santa Lucía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reuteri gotas; Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority	Dietary supplement: Reuteri gotas; Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
Active Comparator: AB- Kolicare; Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority	Dietary supplement: AB-Kolicare; Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 for 21 days, 5 drops/day preferably during the first intake of milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of crying and fussing	Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.	21 days
Percent of responders	Percent of subjects whose change in crying time is equal or larger than 50% from baseline	7, 14, 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of regurgitations	Change in daily number of regurgitations	21 days
Bowel movements	Change in daily number of bowel movements	21 days
Food intake	Frequency of food intake	21 days
Parent's anxiety and depression	Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.	baseline, day 21
Fecal microbiome	Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis	baseline, day 21
Fecal calprotectin	Change on calprotectin in feces	baseline, day 21
Adverse events	Frequency of adverse events reported on dairy report form after randomization and until day 21	21 days

Collaborators and Investigators

• Sponsor: AB Biotics, SA

Publications and helpful links

General Publications

• Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
• Moreno-Villares JM, Andrade-Platas D, Soria-Lopez M, Colome-Rivero G, Catalan Lamban A, Martinez-Figueroa MG, Espadaler-Mazo J, Valverde-Molina J. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. Eur J Pediatr. 2024 Dec;183(12):5371-5381. doi: 10.1007/s00431-024-05806-x. Epub 2024 Oct 11.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infant colic, probiotic
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Colic
• Other Study ID Numbers: Pro-care 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No