Efficacy and safety of APT198K for the treatment of infantile colic: a pilot study

Vandenplas, Yvan; Bacârea, Anca; Măruşteri, Marius; Bacarea, Vlad; Constantin, Mariana; Mihai, Manolache

doi:10.2217/cer-2016-0059

Cited by 27 publications

(29 citation statements)

References 29 publications

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“…In a pilot study in 46 infants aged 3--16 weeks with infantile colic, the administration of xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01 significantly decreased the mean duration of crying episodes, in comparison with a lactase dietary supplement. These results suggest a role of xyloglucan in the management of infantile coli, although further research in larger studies is needed [ 76 ].…”

Section: Clinical Studies With Xyloglucan In Infantile Colicmentioning

confidence: 99%

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

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Gómez‐Guillén

Montero

2018

IJMS

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Disruption of the epithelial barrier function has been recently associated with a variety of diseases, mainly at intestinal level, but also affecting the respiratory epithelium and other mucosal barriers. Non-pharmacological approaches such as xyloglucan, with demonstrated protective barrier properties, are proposed as new alternatives for the management of a wide range of diseases, for which mucosal disruption and, particularly, tight junction alterations, is a common characteristic. Xyloglucan, a natural polysaccharide derived from tamarind seeds, possesses a “mucin-like” molecular structure that confers mucoadhesive properties, allowing xyloglucan formulations to act as a barrier capable of reducing bacterial adherence and invasion and to preserve tight junctions and paracellular flux, as observed in different in vitro and in vivo studies. In clinical trials, xyloglucan has been seen to reduce symptoms of gastroenteritis in adults and children, nasal disorders and dry eye syndrome. Similar mucosal protectors containing reticulated proteins have also been useful for the treatment of irritable bowel syndrome and urinary tract infections. The role of xyloglucan in other disorders with mucosal disruption, such as dermatological or other infectious diseases, deserves further research. In conclusion, xyloglucan, endowed with film-forming protective barrier properties, is a safe non-pharmacological alternative for the management of different diseases, such as gastrointestinal and nasal disorders.

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Section: Clinical Studies With Xyloglucan In Infantile Colicmentioning

confidence: 99%

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

Piqué

Gómez‐Guillén

Montero

2018

IJMS

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“…The resting periods between heating periods allow surviving spores to develop into bacterial cells, which will then be destroyed by the next day’s heating. Tyndallized probiotics L. reuteri SGL01 100 × 10 9 colony-forming units (CFU)/g and B. breve SGB01 100 × 10 9 CFU/g were recently compared to lactase in a clinical trial 53 . Both interventions reduced crying time, which may be related to the placebo effect or to the fact that both interventions are indeed effective, but APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic 53 .…”

Section: Managementmentioning

confidence: 99%

“…Tyndallized probiotics L. reuteri SGL01 100 × 10 9 colony-forming units (CFU)/g and B. breve SGB01 100 × 10 9 CFU/g were recently compared to lactase in a clinical trial 53 . Both interventions reduced crying time, which may be related to the placebo effect or to the fact that both interventions are indeed effective, but APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic 53 . A trial comparing a combination of Matricaria chamomilla , Melissa officinalis , and tyndallized L. acidophilus (HA122) with L. reuteri DSM 17938 and with simethicone showed that simethicone was not effective but both other arms were equally effective 29 .…”

Section: Managementmentioning

confidence: 99%

Recent advances in understanding and managing infantile colic

et al. 2018

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A newborn brings joy to the family. Crying belongs to the spectrum of normal behaviour of young infants. However, although it occurs in about 20% of all infants, unsoothable and persistent crying in young infants distresses the family, although it is usually benign. The aetiology of infantile colic remains unknown, although an unbalanced gastro-intestinal microbiome, increased intestinal permeability, and chronic inflammation are involved, as well as behavioural factors, including over- and under-stimulation. It is a challenge for healthcare professionals to decide when organic disease needs to be excluded. Parental stress is a reason for babies to cry more, inducing a vicious cycle. Therefore, parental reassurance with explanatory guidance is the cornerstone of management. The placebo effect is estimated to be as high as 50%. If an intervention is felt to be necessary to offer further support to the baby and family, it is important to choose the options for which there is some efficacy without adverse effects. There is evidence that some specific probiotic strains such as Lactobacillus reuteri DSM 19378, especially in breastfed infants, are effective. However, there are also promising data for some synbiotics and/or killed or tyndallized bacteria, as well as substances decreasing intestinal permeability. Formula management with extensive and/or partial hydrolysates may also bring relief. But, above all, offering parental support remains imperative.

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“…In experimental animal models [ 20 ] and in human clinical trials [ 21 , 22 ], positive effects of heat-killed bacteria in different conditions have been observed, such as probiotic administration in neonates, without the risks associated with live bacteria [ 23 , 24 ]. Preparations with dead or live microorganisms and metabolites have shown good biological properties in terms of reestablishing intestinal homeostasis; in many cases, these effects are similar to those obtained with the administration of live bacteria [ 20 , 25 ].…”

Section: Introductionmentioning

confidence: 99%

Impact of Heat-Killed Lactobacillus casei Strain IMAU60214 on the Immune Function of Macrophages in Malnourished Children

et al. 2020

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Malnutrition is commonly associated with immunological deregulation, increasing the risk of infectious illness and death. The objective of this work was to determine the in vitro effects of heat-killed Lactobacillus casei IMAU60214 on monocyte-derived macrophages (MDMs) from well-nourished healthy children, well-nourished infected children and malnourished infected children, which was evaluated by an oxygen-dependent microbicidal mechanism assay of luminol-increase chemiluminescence and the secretion of tumor necrosis factor (TNF-α), interleukin (IL-1β), IL-6 and IL-10, as well as phagocytosis using zymosan and as its antibacterial activity against Salmonella typhimurium, Escherichia coli and Staphylococcus aureus. We found that reactive oxygen species (ROS), secretion cytokines (TNFα, IL-1β, IL-6 and IL-10 levels), phagocytosis and bactericidal capacity increased in all groups after pre-treatment with heat-killed L. casei IMAU60214 at a ratio of 500:1 (bacteria:MDM) over 24 h compared with MDM cells without pre-treatment. The results could indicate that heat-killed L. casei IMAU60214 is a potential candidate for regulating the immune function of macrophages.

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Efficacy and safety of APT198K for the treatment of infantile colic: a pilot study

Abstract: APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .

Cited by 27 publications

References 29 publications

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

Xyloglucan, a Plant Polymer with Barrier Protective Properties over the Mucous Membranes: An Overview

Recent advances in understanding and managing infantile colic

Impact of Heat-Killed Lactobacillus casei Strain IMAU60214 on the Immune Function of Macrophages in Malnourished Children

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