Infant Colic Treatment With Probiotics

Mónica Olivares Martín; PhD

Status and phase: Completed; Phase 2

Conditions: Infant Colic

Treatments: Dietary Supplement: B. breve plus L. fermentum; Drug: Simethicone 20 MG; Dietary Supplement: B. breve

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03467334

P040

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 3 to 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

B. breve

Experimental group

Description:

Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.

Treatment:

Dietary Supplement: B. breve

B. breve plus L. fermentum

Experimental group

Description:

Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.

Treatment:

Dietary Supplement: B. breve plus L. fermentum

Simethicone 20 mg

Active Comparator group

Description:

Control group that will receive simethicone 4 times (10 drops) a day.

Treatment:

Drug: Simethicone 20 MG