Prospective Study to Determine the Factors Influencing Infant Colic

Not Applicable

Completed

• Conditions: Infant Colic
• Interventions: Dietary Supplement: Reuteri gotas; Dietary Supplement: AB-Kolicare

• Registration Number: NCT05271747
• Lead Sponsor: AB Biotics, SA

Brief 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study First Posted: 2022-03-09
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reuteri gotas	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
AB- Kolicare	AB-Kolicare	Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Primary Outcome Measures

Name	Time	Method
Percent of responders	7, 14, 21 days	Percent of subjects whose change in crying time is equal or larger than 50% from baseline
Duration of crying and fussing	21 days	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.

Secondary Outcome Measures

Name	Time	Method
Food intake	21 days	Frequency of food intake
Fecal calprotectin	baseline, day 21	Change on calprotectin in feces
Number of regurgitations	21 days	Change in daily number of regurgitations
Bowel movements	21 days	Change in daily number of bowel movements
Parent's anxiety and depression	baseline, day 21	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.
Fecal microbiome	baseline, day 21	Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis
Adverse events	21 days	Frequency of adverse events reported on dairy report form after randomization and until day 21

Trial Locations

Locations (4)

HM Hospitals; 🇪🇸 Barcelona, Spain

Hospital Medica Sur, room 108, tower 2; 🇲🇽 Mexico City, Mexico

University Hospital Santa Lucía; 🇪🇸 Cartagena, Murcia, Spain

Hm Hospitals; 🇪🇸 Madrid, Spain