Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz87 enrolled

Overview

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

Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infantile Colic

Interventions

Simethicone SolutionDRUG

Oral daily treatment for four weeks

Vivatlac BabyDIETARY_SUPPLEMENT

Oral daily treatment for four weeks

Eligibility

Sex: ALLMin age: 3 WeeksMax age: 6 Weeks

Medical Language ↔ Plain English

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

Locations (2)

GP Practice Pro Familia

Koziegłowy, Poland

Medical University in Poznań

Poznan, Poland

Outcomes

Primary Outcomes

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

Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Time frame: Three weeks

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

Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Time frame: Three weeks

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

Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Time frame: Three weeks

Data from ClinicalTrials.gov

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