Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
NCT ID: NCT04487834
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2020-04-16
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Simethicone Solution
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.
Simethicone Solution
Oral daily treatment for four weeks
Vivatlac Baby
Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® 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.
Vivatlac Baby
Oral daily treatment for four weeks
Interventions
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Simethicone Solution
Oral daily treatment for four weeks
Vivatlac Baby
Oral daily treatment for four weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous treatment with antibiotics
3 Weeks
6 Weeks
ALL
No
Sponsors
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The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
OTHER
Responsible Party
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Principal Investigators
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Hanna Krauss, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Applied Sciences in Kalisz, Poland
Locations
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GP Practice Pro Familia
Koziegłowy, , Poland
Medical University in Poznań
Poznan, , Poland
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol: Effects of Simethicone and Multilac Baby in Infantile Colic
Document Type: Study Protocol: Annex Patient Assessment Sheet Day 0
Document Type: Study Protocol: Annex 24 Hours Parental Diary Form
Document Type: Statistical Analysis Plan
Related Links
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In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters
Other Identifiers
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Kalisz 2020-01
Identifier Type: -
Identifier Source: org_study_id