Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Infantile Colic Clinical Trial

Official title:

Effects of Simethicone and Vivatlac Baby in Infantile Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487834
• Other study ID #: Kalisz 2020-01
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Colic
• Infantile Colic

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

External Links

•   In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters