Infant Colic Treatment With Probiotics

Sponsor

Mónica Olivares Martín; PhD (Industry)

Overall Status

Completed

CT.gov ID

NCT03467334

Collaborator

European Regional Development Fund (Other), Ministerio de Ciencia e Innovación, Spain (Other)

156

Enrollment

Location

Arms

24.5

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infant Colic	Dietary Supplement: B. breve Dietary Supplement: B. breve plus L. fermentum Drug: Simethicone 20 MG	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 31, 2017

Actual Primary Completion Date :

Jun 15, 2019

Actual Study Completion Date :

Jun 15, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Crying time [4 weeks]
Crying time in minutes per day

Secondary Outcome Measures

Responders to treatment on weeks 1, 2, 3 and 4 [4 weeks]
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
Gut microbiota [4 weeks]
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.
Stool carbohydrates [4 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Weeks to 12 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio Andaluz de Salud	Granada		Spain	10012

Sponsors and Collaborators

Mónica Olivares Martín; PhD
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)