Back to resultsEffects of Multilac Baby on Crying Behavior of Colicky Babies
Primary Purpose
Infantile Colic
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Simethicone Solution
Multilac Baby
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic
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
Sites / Locations
- GP Practice Pro Familia
- Medical University in Poznań
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Simethicone Solution
Multilac Baby
Arm Description
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.
Outcomes
Primary Outcome Measures
Change of days of crying
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.
Change of average duration of evening crying
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.
Change of average number of crying phases per day
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04487834
First Posted
July 22, 2020
Last Updated
July 26, 2020
Sponsor
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
1. Study Identification
Unique Protocol Identification Number
NCT04487834
Brief Title
Effects of Multilac Baby on Crying Behavior of Colicky Babies
Official Title
Effects of Simethicone and Multilac Baby in Infantile Colic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open trial with two parallel arms, assessing the effects of Simethicone and Multilac 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 Multilac Baby). Multilac 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simethicone Solution
Arm Type
Active Comparator
Arm Description
Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
Arm Title
Multilac Baby
Arm Type
Experimental
Arm Description
Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.
Intervention Type
Drug
Intervention Name(s)
Simethicone Solution
Other Intervention Name(s)
Simethicone
Intervention Description
Oral daily treatment for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Multilac Baby
Other Intervention Name(s)
Multistrain Synbiotic
Intervention Description
Oral daily treatment for four weeks
Primary Outcome Measure Information:
Title
Change of days of crying
Description
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.
Time Frame
Three weeks
Title
Change of average duration of evening crying
Description
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.
Time Frame
Three weeks
Title
Change of average number of crying phases per day
Description
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.
Time Frame
Three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
6 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna Krauss, Prof.
Organizational Affiliation
University of Applied Sciences in Kalisz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
GP Practice Pro Familia
City
Koziegłowy
ZIP/Postal Code
62028
Country
Poland
Facility Name
Medical University in Poznań
City
Poznan
ZIP/Postal Code
61701
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32403297
Citation
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.
Results Reference
background
PubMed Identifier
33765904
Citation
Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246756/
Description
In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters
Learn more about this trial
Effects of Multilac Baby on Crying Behavior of Colicky Babies
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