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...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-02-01
|
| Series: | Microorganisms |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-2607/10/2/430 |
| _version_ | 1797477826346090496 |
|---|---|
| author | Malgorzata Bernatek Jacek Piątek Marcin Pszczola Hanna Krauss Janina Antczak Paweł Maciukajć Henning Sommermeyer |
| author_facet | Malgorzata Bernatek Jacek Piątek Marcin Pszczola Hanna Krauss Janina Antczak Paweł Maciukajć Henning Sommermeyer |
| author_sort | Malgorzata Bernatek |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T21:23:15Z |
| format | Article |
| id | doaj.art-f7470e0f8ef84262afbb0bc240515070 |
| institution | Directory Open Access Journal |
| issn | 2076-2607 |
| language | English |
| last_indexed | 2024-03-09T21:23:15Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Microorganisms |
| spelling | doaj.art-f7470e0f8ef84262afbb0bc2405150702023-11-23T21:16:05ZengMDPI AGMicroorganisms2076-26072022-02-0110243010.3390/microorganisms10020430Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized StudyMalgorzata Bernatek0Jacek Piątek1Marcin Pszczola2Hanna Krauss3Janina Antczak4Paweł Maciukajć5Henning Sommermeyer6Department of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, PolandDepartment of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, PolandDepartment of Genetics and Animal Breeding, Faculty of Veterinary Medicine and Animal Science, Poznan University of Life Sciences, Wolynska 33, 60-637 Poznan, PolandDepartment of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, PolandState Hospital Jarocin, Szpitalna 1, 63-200 Jarocin, PolandGP Clinic Brody, Stanisława Staszica 3, 27-230 Brody, PolandDepartment of Health Sciences, Calisia University, Nowy Swiat 4, 62-800 Kalisz, PolandThe 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.https://www.mdpi.com/2076-2607/10/2/430coliccolicky babiescryingdysbiosisfecal calprotectingut inflammation |
| spellingShingle | Malgorzata Bernatek Jacek Piątek Marcin Pszczola Hanna Krauss Janina Antczak Paweł Maciukajć Henning Sommermeyer Nine-Strain Bacterial Synbiotic Improves Crying and Lowers Fecal Calprotectin in Colicky Babies—An Open-Label Randomized Study Microorganisms colic colicky babies crying dysbiosis fecal calprotectin gut inflammation |
| 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 | colic colicky babies crying dysbiosis fecal calprotectin gut inflammation |
| url | https://www.mdpi.com/2076-2607/10/2/430 |
| work_keys_str_mv | AT malgorzatabernatek ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT jacekpiatek ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT marcinpszczola ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT hannakrauss ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT janinaantczak ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT pawełmaciukajc ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy AT henningsommermeyer ninestrainbacterialsynbioticimprovescryingandlowersfecalcalprotectinincolickybabiesanopenlabelrandomizedstudy |