Infant Colic Treatment With Probiotics

Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic

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.

Study Overview

• Status: Completed
• Conditions: Infant Colic
• Intervention / Treatment: Dietary supplement: B. breve; Dietary supplement: B. breve plus L. fermentum; Drug: Simethicone 20 MG

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 10012
    • Servicio Andaluz de Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B. breve; 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.	Dietary supplement: B. breve; Bifidobacterium probiotic strain at 1E+08 cfu/day
Experimental: B. breve plus L. fermentum; 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.	Dietary supplement: B. breve plus L. fermentum; Probiotic combination at 2E+08 cfu/day
Active Comparator: Simethicone 20 mg; Control group that will receive simethicone 4 times (10 drops) a day.	Drug: Simethicone 20 MG; Standard treatment for infant colic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying time	Crying time in minutes per day	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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).	4 weeks

Collaborators and Investigators

• Sponsor: Mónica Olivares Martín; PhD
• Collaborators: European Regional Development Fund; Ministerio de Ciencia e Innovación, Spain
• Investigators: Principal Investigator: José Maldonado, MD, PhD, Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2017
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Bifidobacterium breve; Lactobacillus fermentum; Infant colic
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: P040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No