Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies
NCT ID: NCT04666324
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-12-31
2021-09-30
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
Multilac Baby
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.
Multilac Baby
Oral daily treatment for four weeks
Interventions
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Simethicone Solution
Oral daily treatment for four weeks
Multilac 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
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Locations
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GP Clinic "Panaceum"
Brody, , Poland
GP Clinic "Pro Familia"
Koziegłowy, , Poland
Countries
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Central Contacts
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Facility Contacts
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Marek Maciukajc, Dr.
Role: primary
Jacek Piatek, Prof.
Role: backup
Hanna Krauss, Prof.
Role: primary
Jacek Piatek, Prof.
Role: backup
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.
Sommermeyer H, Bernatek M, Pszczola M, Krauss H, Piatek J. Supporting the diagnosis of infantile colic by a point of care measurement of fecal calprotectin. Front Pediatr. 2022 Sep 29;10:978545. doi: 10.3389/fped.2022.978545. eCollection 2022.
Bernatek M, Piatek J, Pszczola M, Krauss H, Antczak J, Maciukajc P, Sommermeyer H. Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies-An Open-Label Randomized Study. Microorganisms. 2022 Feb 12;10(2):430. doi: 10.3390/microorganisms10020430.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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Kalisz 2020-02
Identifier Type: -
Identifier Source: org_study_id