Infant Colic Treatment With Probiotics

Phase 2

Completed

• Conditions: Infant Colic
• Interventions: Drug: Simethicone 20 MG; Dietary Supplement: B. breve; Dietary Supplement: B. breve plus L. fermentum

• Registration Number: NCT03467334
• Lead Sponsor: Mónica Olivares Martín; PhD

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.

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 Timeline

• Study Start: 2017-05-31
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simethicone 20 mg	Simethicone 20 MG	Control group that will receive simethicone 4 times (10 drops) a day.
B. breve	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.
B. breve plus L. fermentum	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.

Primary Outcome Measures

Name	Time	Method
Crying time	4 weeks	Crying time in minutes per day

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Servicio Andaluz de Salud; 🇪🇸 Granada, Spain