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Clinical Trial of L. Reuteri in Infantile Colic 2017

NCT03360253 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2019-07-30

No results posted yet for this study

Summary

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

L. reuteri DSM 17938 in drops

L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle

OTHER

Placebo

The placebo consists of an identical formulation except that the L. reuteri is not present

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Innovacion y Desarrollo de Estrategias en Salud

    lead OTHER

Principal Investigators

  • Pedro Gutierrez-Castrellon, DSc · Hospital General Dr. Manuel Gea Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-11-30
Completion
2020-01-30

Countries

  • Mexico

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 NCT03360253 on ClinicalTrials.gov