Prospective Study to Determine the Factors Influencing Infant Colic

AB Biotics, SA112 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

112

Conditions

Infant Colic

Interventions

AB-KolicareDIETARY_SUPPLEMENT

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

Reuteri gotasDIETARY_SUPPLEMENT

Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.

Eligibility

Sex: ALLMin age: 2 WeeksMax age: 12 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 21 days

Percent of responders

Percent of subjects whose change in crying time is equal or larger than 50% from baseline

Time frame: 7, 14, 21 days

Secondary Outcomes

Number of regurgitations

Change in daily number of regurgitations

Time frame: 21 days

Bowel movements

Change in daily number of bowel movements

Time frame: 21 days

Food intake

Frequency of food intake

Time frame: 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.

Time frame: baseline, day 21

Fecal microbiome

Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis

Time frame: baseline, day 21

Data from ClinicalTrials.gov

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