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Infant Colic Treatment With Probiotics

NCT03467334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-07-23

No results posted yet for this study

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.

Conditions

  • Infant Colic

Interventions

DIETARY_SUPPLEMENT

B. breve

Bifidobacterium probiotic strain at 1E+08 cfu/day

DIETARY_SUPPLEMENT

B. breve plus L. fermentum

Probiotic combination at 2E+08 cfu/day

DRUG

Simethicone 20 MG

Standard treatment for infant colic

Sponsors & Collaborators

  • European Regional Development Fund

    collaborator OTHER

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Mónica Olivares Martín; PhD

    lead INDUSTRY

Principal Investigators

  • José Maldonado, MD, PhD · Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-06-15
Completion
2019-06-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03467334 on ClinicalTrials.gov