CompletedPhase 2

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Poland87 participantsStarted 2020-04-16

Plain-language summary

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Who can participate

Age range3 Weeks – 6 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosed for infantile colic according to Wessel's criteria Exclusion Criteria: * previous treatment with probiotic or synbiotic * previous treatment with antibiotics

What they're measuring

Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline

Timeframe: Three weeks

Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent

Timeframe: Three weeks

Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent

Timeframe: Three weeks

Trial details

NCT IDNCT04487834

SponsorThe President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

Results submitted2023-01-31

View on ClinicalTrials.gov More Infantile Colic trials