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Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study

The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3–6 weeks, diagnosed using the Wessel criteria. The open-label stu...

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Autores principales: Bernatek, Malgorzata, Piątek, Jacek, Pszczola, Marcin, Krauss, Hanna, Antczak, Janina, Maciukajć, Paweł, Sommermeyer, Henning
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8875711/
https://www.ncbi.nlm.nih.gov/pubmed/35208884
http://dx.doi.org/10.3390/microorganisms10020430
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author Bernatek, Malgorzata
Piątek, Jacek
Pszczola, Marcin
Krauss, Hanna
Antczak, Janina
Maciukajć, Paweł
Sommermeyer, Henning
author_facet Bernatek, Malgorzata
Piątek, Jacek
Pszczola, Marcin
Krauss, Hanna
Antczak, Janina
Maciukajć, Paweł
Sommermeyer, Henning
author_sort Bernatek, Malgorzata
collection PubMed
description The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3–6 weeks, diagnosed using the Wessel criteria. The open-label study comprised a control group of non-colicky babies (n = 20) and two parallel treatment groups (each n = 50) to which colicky babies were randomly and equally assigned to receive the multi-strain synbiotic or simethicone orally for 28 days. Primary outcome measures were the change in daily crying duration and the level of fecal calprotectin on days 1 and 28 of the study. Administration of the synbiotic resulted in a rechange of crying duration of −7.18 min/day of treatment, while simethicone had a significantly smaller effect (−5.74 min/day). Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies. Treatment with the nine-strain synbiotic resulted in a significant lowering of fecal calprotectin at the end of the study, while no such effect was found for simethicone. No adverse effects were reported. Study results confirm earlier findings of crying duration reductions in colicky babies by the synbiotic, an effect that might be linked to its anti-inflammatory properties.
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spelling pubmed-88757112022-02-26 Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study Bernatek, Malgorzata Piątek, Jacek Pszczola, Marcin Krauss, Hanna Antczak, Janina Maciukajć, Paweł Sommermeyer, Henning Microorganisms Article The aim of this study (ClinicalTrials.gov registration NCT04666324) was to determine the effects of a nine-strain synbiotic and simethicone on the duration of crying and the gut inflammation marker calprotectin in colicky babies aged 3–6 weeks, diagnosed using the Wessel criteria. The open-label study comprised a control group of non-colicky babies (n = 20) and two parallel treatment groups (each n = 50) to which colicky babies were randomly and equally assigned to receive the multi-strain synbiotic or simethicone orally for 28 days. Primary outcome measures were the change in daily crying duration and the level of fecal calprotectin on days 1 and 28 of the study. Administration of the synbiotic resulted in a rechange of crying duration of −7.18 min/day of treatment, while simethicone had a significantly smaller effect (−5.74 min/day). Fecal calprotectin levels in colicky babies were significantly elevated compared to those in non-colicky babies. Treatment with the nine-strain synbiotic resulted in a significant lowering of fecal calprotectin at the end of the study, while no such effect was found for simethicone. No adverse effects were reported. Study results confirm earlier findings of crying duration reductions in colicky babies by the synbiotic, an effect that might be linked to its anti-inflammatory properties. MDPI 2022-02-12 /pmc/articles/PMC8875711/ /pubmed/35208884 http://dx.doi.org/10.3390/microorganisms10020430 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bernatek, Malgorzata
Piątek, Jacek
Pszczola, Marcin
Krauss, Hanna
Antczak, Janina
Maciukajć, Paweł
Sommermeyer, Henning
Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title_full Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title_fullStr Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title_full_unstemmed Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title_short Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study
title_sort nine-strain bacterial synbiotic improves crying and lowers fecal calprotectin in colicky babies—an open-label randomized study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8875711/
https://www.ncbi.nlm.nih.gov/pubmed/35208884
http://dx.doi.org/10.3390/microorganisms10020430
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