Status:
COMPLETED
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Lead Sponsor:
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Conditions:
Infantile Colic
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
Brief Summary
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- diagnosed for infantile colic according to Wessel's criteria
Exclusion
- previous treatment with probiotic or synbiotic
- previous treatment with antibiotics
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04487834
Start Date
April 16 2020
End Date
June 30 2020
Last Update
November 22 2023
Active Locations (2)
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1
GP Practice Pro Familia
Koziegłowy, Poland, 62028
2
Medical University in Poznań
Poznan, Poland, 61701