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Clinical trial

Effects of Simethicone and Vivatlac Baby in Infantile Colic

ID
Name
Kalisz 2020-01
Description
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
Trial arms
Trial start
2020-04-16
Estimated PCD
2020-06-30
Trial end
2020-06-30
Status
Completed
Phase
Early phase I
Treatment
Simethicone Solution
Oral daily treatment for four weeks
Arms:
Simethicone Solution
Other names:
Simethicone
Vivatlac Baby
Oral daily treatment for four weeks
Arms:
Vivatlac Baby
Other names:
Multistrain Synbiotic
Size
87
Primary endpoint
Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
Three weeks
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
Three weeks
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
Three weeks
Eligibility criteria
Inclusion Criteria: * diagnosed for infantile colic according to Wessel's criteria Exclusion Criteria: * previous treatment with probiotic or synbiotic * previous treatment with antibiotics
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 87, 'type': 'ACTUAL'}}
Updated at
2023-11-22

1 organization

1 product

1 indication

Organization
Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Product
Simethicone
Indication
Colic