Prospective Study to Determine the Factors Influencing Infant Colic

AB Biotics

Status: Completed

Conditions: Infant Colic

Treatments: Dietary Supplement: Reuteri gotas; Dietary Supplement: AB-Kolicare

Study type: Interventional

Funder types: Industry

Identifiers

NCT05271747

Pro-care 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 2 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

AB- Kolicare

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: AB-Kolicare

Reuteri gotas

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Reuteri gotas