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Lactocare Baby Drops in Infants Colic

NCT02839239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2018-01-18

No results posted yet for this study

Summary

The objective of this study is to determine an efficacy of the combination of L. rhamnosus 19070-2 (FloraActiveTM) and L. reuteri DSM 122460 (FloraActiveTM) in decreasing cry/fuss in infants aged 4 through 12 weeks with IC. The active group of infants will receive lactobacilli with vitamin D3 while the control group will receive vitamin D3 2 times daily as oil suspension for 28 days. Duration of infant fuss/cry will be measured at baseline and at the end of intervention to define a difference between the groups

Conditions

  • Infant Colic

Interventions

DIETARY_SUPPLEMENT

Drops with lactobacilli and vitamin D3

Oil suspension with lactobacilli and vitamin D3

DIETARY_SUPPLEMENT

Drops with vitamin D3

Oil suspension with vitamin D3

Sponsors & Collaborators

  • Lviv National Medical University

    collaborator OTHER

  • Biocare Copenhagen A/S

    lead INDUSTRY

Principal Investigators

  • Soren Thomsen · Biocare Copenhagen A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-09
Primary Completion
2018-01-15
Completion
2018-01-15

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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 NCT02839239 on ClinicalTrials.gov