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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04487834
Other study ID # Kalisz 2020-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 16, 2020
Est. completion date June 30, 2020

Study information

Verified date November 2023
Source The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 3 Weeks to 6 Weeks
Eligibility Inclusion Criteria: - diagnosed for infantile colic according to Wessel's criteria Exclusion Criteria: - previous treatment with probiotic or synbiotic - previous treatment with antibiotics

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Simethicone Solution
Oral daily treatment for four weeks
Dietary Supplement:
Vivatlac Baby
Oral daily treatment for four weeks

Locations

Country Name City State
Poland GP Practice Pro Familia Kozieglowy
Poland Medical University in Poznan Poznan

Sponsors (1)

Lead Sponsor Collaborator
The President Stanislaw Wojciechowski State University of Applied Sciences in Kalisz

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Three weeks
Primary 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. Three weeks
Primary 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. Three weeks
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