Infant Colic Treatment With Probiotics

Infant Colic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03467334
• Other study ID #: P040
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2017
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

Dietary Supplement:
• B. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day
• B. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day

Drug:
• Simethicone 20 MG
Standard treatment for infant colic

Locations

Country	Name	City	State
Spain	Servicio Andaluz de Salud	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Mónica Olivares Martín; PhD	European Regional Development Fund, Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crying time	Crying time in minutes per day	4 weeks
Secondary	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
Secondary	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
Secondary	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