Infant Colic Treatment With Probiotics

Mónica Olivares Martín; PhD156 enrolled

Overview

This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic. The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone. It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Infant Colic

Interventions

B. breveDIETARY_SUPPLEMENT

Bifidobacterium probiotic strain at 1E+08 cfu/day

B. breve plus L. fermentumDIETARY_SUPPLEMENT

Probiotic combination at 2E+08 cfu/day

Simethicone 20 MGDRUG

Standard treatment for infant colic

Eligibility

Sex: ALLMin age: 3 WeeksMax age: 12 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Infants from 3 to 12 weeks of age * Born at least at week 34 * Birth weight equal to or greater than 2000 grams * Fulfill the criteria of Rome III * Informed consent signed by parents or guardians Exclusion Criteria: * Failure to thrive * Antibiotic treatment less than 2 weeks before the study or during the study * Take probiotics as a treatment, different from the one that could contain the powdered infant formula * Abandon breastfeeding and switch to infant formula * Failure to comply with the study protocol

Locations (1)

Servicio Andaluz de Salud

Granada, Spain

Outcomes

Primary Outcomes

Crying time

Crying time in minutes per day

Time frame: 4 weeks

Secondary Outcomes

Responders to treatment on weeks 1, 2, 3 and 4

Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline

Time frame: 4 weeks

Gut microbiota

Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR.

Time frame: 4 weeks

Stool carbohydrates

Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4).

Time frame: 4 weeks

Data from ClinicalTrials.gov

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