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OpenTrials
Completed

NCT Number: NCT04487834

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

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

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Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

3 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GP Practice Pro Familia, Koziegłowy, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed for infantile colic according to Wessel's criteria

Exclusion criteria

  • previous treatment with probiotic or synbiotic
  • previous treatment with antibiotics

Treatment and study plan

Simethicone Solution

Drug

Oral daily treatment for four weeks

Other names: Simethicone

Vivatlac Baby

Dietary Supplement

Oral daily treatment for four weeks

Other names: Multistrain Synbiotic

Primary outcomes

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

    Time frame: Three weeks

    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.

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

    Time frame: Three weeks

    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.

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

    Time frame: Three weeks

    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.

Sponsors and collaborators

Lead sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Other

Registry information

Official study title

Effects of Simethicone and Vivatlac Baby in Infantile Colic

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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