KITY Study Protocol: A Randomised Controlled Trial for Eczema Prevention by Ingestion of Kestose in High‐Risk Neonates DOI Open Access
Mayako Saito‐Abe, Kenji Toyokuni,

Hisako Ogasawara

et al.

Clinical & Experimental Allergy, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 18, 2024

Atopic eczema represents one of the prevalent dermatological conditions encountered in routine clinical settings, with cohort investigations revealing that approximately 30% infants exhibit symptoms during early stages life. This condition serves as a critical precursor to series allergic manifestations termed 'atopic march', thereby underscoring significance implementing preventive measures at an stage [1]. Eczema is characterised multifactorial disorder, indicating integrative approach addressing various interconnected elements imperative. Investigations centered around 'skin-gut axis' have been progressing, microbiome instrumental pathophysiology dermal conditions. The operates regulator immune system, facilitating bidirectional communication diverse tissues and organs sustain homeostasis. Dysbiosis, defined imbalance within microbiome, both skin gastrointestinal tract, significantly correlated aberrant responses recognised contributing factor onset eczema. In recent years, it has posited enteral strategies aimed modulating microbiomes could serve promising avenue for management prophylaxis diseases. Our studies (T-CHILD JECS) indicated relationship between antibiotic exposure disrupting gut incidence conditions, including [2] FPIES [3] general populations, suggesting enhancing microbiota equilibrium such prebiotics may play role prevention. However, specific advocated by existing guidelines currently lack robust empirical support. Notwithstanding, from scientific viewpoint, promotion balanced highly plausible exert effects against development Prebiotics are compounds remain unaltered unabsorbed proximal functioning substrates intestinal preservation health. Grüber et al. [4] demonstrated formulation incorporating oligosaccharides time birth mitigate Nonetheless, 2017, Cuello-Garcia [5] published comprehensive systematic review assessing prophylactic impact on eczema, which revealed no statistically significant variations. showed overall effect was reduction risk when compared control group, although confidence interval did not exclude null (RR, 0.68; 95% CI, 0.40–1.15; 2030 participants; six trials). Among array prebiotics, our investigation concentrated specifically kestose. Kestose classified trisaccharides, comprising combination sucrose fructose via β-1,1-glycosidic linkage. resistant digestion. ingested orally, kestose transported lower tract without being digested [6]. It selectively utilised microbiota. shown enhance proliferation butyrate-producing bacterial strains (Faecalibacterium prausnitzii) [7], elevating butyrate concentrations. Butyrate anticipated facilitate differentiation regulatory T cells (Tregs) manifestations. Shibata [8] reported findings regarding therapeutic efficacy context involving 30 children below age three diagnosed intervention group daily over 12-week period, whereas consumed maltose. Post-intervention, SCORAD score registered 19.5 37.5 maltose signifying amelioration (p < 0.001). As milk allergy children, enhanced relative abundance Faecalibacterium species modestly increased dose cow's tolerated [9]. there exists dearth prior examining preventative We undertaking double-blind, randomised, two-group parallel comparison study kestose, prebiotic, high-risk contrasting intake (Kestose Intake prevention atopic dermatitis Tokyo; KITY Study) registration Japan Registry Clinical Trials (jRCT): ID: jRCTs031220020 (https://jrct.niph.go.jp/en-latest-detail/jRCTs031220020). does administer pregnant women (Figure 1). protocol this article's Online Repository 10.5281/zenodo.13905238. K.Y.-H., M.S.-A., Y.I. Y.O. conceived idea study. All authors contributed fix protocol. K.P. contributes statistics. T.K. advised procedure. M.S.-A. drafted original manuscript. K.T., H.O. D.H. recruited followed participants. Y.H., H.M. K.M. handled blood samples. T.F., K.Y.-H. supervised conduct reviewed manuscript draft revised critically intellectual content. approved publication final version Ms. Miwako Seike Mariko Noda developed data plan Dr. Mayumi Sako, Nozomi Fukui Tomoko Matsushita monitoring Kozue Miyake, Yuki Saito, Junko Ikeda, Saki Ueno, Saya Kitami, Yukie Miyata, Mr. Sora Nazuka, Sayuri Tateai, Kazuko Hayase, Takako Kimura, Nishimura, Kumiko Watabe Emiko Matsuzaka supported research based Japanese Act (Act No. 16 14 April 2017) described website (https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000213334.pdf). Certified Review Board National Center Child Health Development February 24, 2022 (Reference number: CRB3200005). trial (https://jrct.niph.go.jp/en-latest-detail/jRCTs031220020) 13, 2022. parents provided their written consent participation before we enrolled trial. conducted collaborative project funded Natural Science Co. Ltd. involved certain aspects (such provision delivery test sugar, sugar cosmetics participants) preparing presentation materials assisting writing conference presentations). they analysis results. There conflict interest planning, implementation, interpretation or results would affect rights interests principal investigator manages following Conflict Interest Management Guidance under submitted standard Research approval. Each researcher appropriately any conflicts related standards plans discloses them required academic conferences medical journals presented. support available request corresponding author. publicly due privacy ethical restrictions.

Language: Английский

Topical Anti‐Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta‐Analysis DOI Creative Commons
S. Lax, Eleanor Van Vogt, Bridget Candy

et al.

Clinical & Experimental Allergy, Journal Year: 2024, Volume and Issue: 54(12), P. 960 - 972

Published: Sept. 2, 2024

Eczema is the most burdensome skin condition worldwide and topical anti-inflammatory treatments are commonly used to control symptoms. The relative effectiveness safety of different uncertain.

Language: Английский

Citations

4
Changes and clinical significance of serum vitamin A, 25-(OH)D3, TG2, IL-4 and IL-13 levels in children with eczema DOI
Yulian Li, Zhanhui Wang, Xuehua Li

et al.

Archives of Dermatological Research, Journal Year: 2025, Volume and Issue: 317(1)

Published: Feb. 8, 2025

Language: Английский

Citations

0
DIFENSE Study Protocol: Early Intervention With Difamilast Ointment in Infantile Early‐Onset Atopic Dermatitis for Prevention of Transcutaneous Sensitisation DOI Creative Commons
Kiwako Yamamoto‐Hanada,

Kazuyoshi Okamoto,

Nobuharu Kishimoto

et al.

Clinical & Experimental Allergy, Journal Year: 2025, Volume and Issue: unknown

Published: March 26, 2025

Atopic dermatitis (AD) is acknowledged as the first phase in allergic march, with heightened IgE levels [1] linked to a greater likelihood of experiencing food allergy symptoms [2]. Importantly, occurrence early-onset AD during infancy has been found significantly increase odds ratio for development allergies [3]. Additionally, suitable transdermal and oral interventions may impact trajectory which includes prevention allergies. The 'dual allergen exposure hypothesis' suggested mechanistic framework allergies, since randomised controlled trials (RCTs) have validated effectiveness both treatments, this hypothesis effectively evolved into an established theory. Numerous RCTs explored potential moisturisers preventing part skincare strategies. Nevertheless, variations study populations, types moisturisers, frequencies application skin cleansing protocols led inconsistent results. Large-scale carried out Northern Europe United Kingdom not substantiated preventative effects on A Cochrane Review by Kelleher et al. [4] determined that interventions, include use do aid children. distinguished dysfunctional barrier, chronic inflammation pruritus. Interventions focus exclusively restoration barrier through demonstrated be insufficient mitigating onset In addition, RCT performed utilisation mild nonsteroidal topical agent (pimecrolimus) solely affected eczema lesions did inhibit [5]. This outcome indicates minimal anti-inflammatory treatments targeting only visibly regions fall short reducing risk even appears normal shows compromised function inflammatory markers, reflecting existence subclinical at molecular level [6]. As result, successfully percutaneous sensitisation demands well-rounded strategy integrates improvement reaching beyond visible cover nonlesional skin. Infants who manifest 1–2 months life exhibit greatest developing particularly those exhibiting before introduction solid foods, exacerbates their further infants are demographic most urgently needs preventive actions. retrospective analysis conducted our institution indicated prompt intervention following manifestation AD, encompassing proactive treatment administered regions, was associated reduced probability [7]. After achieving remission, maintaining strict control becomes essential lower IgE-mediated Conventional strategies concentrate entirely might sufficient attaining complete PACI Study [8], multicentre trial 2023, early protocol implemented, included applying corticosteroids (TCS) eczematous but also areas. produced 25% decline prevalence egg age 28 weeks relative standard treatment. However, group statistically lowered body weight height compared conventional group, although definitive link between TCS dosage these outcomes (weight height) found. These results suggest importance individualised plans rather than generalised approach all infants. Recently, difamilast ointment [9], new medication, come light adjunctive alongside TCS. Difamilast supports implementation treatment, allowing persistent while alleviating adverse effects, period remission maintenance. To delve deeper atopic (AD), we embarked DIFENSE (jRCTs031240529) (Figure 1). (Early Intervention Ointment Infantile Early-Onset Dermatitis Prevention Transcutaneous Sensitization) multicentre, randomised, comparative exploratory will last 16 weeks. recruit 150 infants, 100 allocated 50 group. primary endpoint assess percentage sensitised serum white, ovomucoid, milk, wheat, omega-5 gliadin, walnut, Jug r 1, peanut Ara h 2 enrolment. Eligible participants aged 42 90 days diagnosed based UKWP criteria within initial symptoms. article's Online Repository https://zenodo.org/records/14942018. We anticipate provide pioneering evidence support advanced designed prevent subsequent K.Y.-H., K.O., N.K., T.K. Y.O. conceived idea study. All authors contributed establishing protocol. supervised conduct reviewed manuscript draft revised it critically intellectual content. approved publication final version manuscript. supported grant from AMED (Grant number, JP 23gn0110078s020, JP24hk010299j0001, JP24ek0410104h0002) Otsuka Pharmaceutical Co. Ltd. English editing Grammarly. National Center Child Health Development signed joint research agreement. K.O. N.K. employees Currently, individual participant data sharing unavailable because IRB permission yet obtained. Individual available after granted. Any queries can emailed Primary Investigator Kiwako Yamamoto-Hanada [email protected].

Language: Английский

Citations

0
Skin and oral intervention for food allergy prevention based on the dual allergen exposure hypothesis DOI Creative Commons
Kiwako Yamamoto‐Hanada, Yukihiro Ohya

Clinical and Experimental Pediatrics, Journal Year: 2023, Volume and Issue: 67(10), P. 477 - 485

Published: June 19, 2023

Early-onset atopic dermatitis increases an individual’s risk of food allergies, suggesting that transcutaneous sensitization may occur through inflamed skin. Regarding allergy causation, the dual allergen exposure hypothesis proposes oral leads to immune tolerance, whereas via skin causes allergies. This suggests it is important induce tolerance and prevent allergic review focuses on breakthrough evidence based involves both interventions for prevention.

Language: Английский

Citations

8
KITY Study Protocol: A Randomised Controlled Trial for Eczema Prevention by Ingestion of Kestose in High‐Risk Neonates DOI Open Access
Mayako Saito‐Abe, Kenji Toyokuni,

Hisako Ogasawara

et al.

Clinical & Experimental Allergy, Journal Year: 2024, Volume and Issue: unknown

Published: Dec. 18, 2024

Atopic eczema represents one of the prevalent dermatological conditions encountered in routine clinical settings, with cohort investigations revealing that approximately 30% infants exhibit symptoms during early stages life. This condition serves as a critical precursor to series allergic manifestations termed 'atopic march', thereby underscoring significance implementing preventive measures at an stage [1]. Eczema is characterised multifactorial disorder, indicating integrative approach addressing various interconnected elements imperative. Investigations centered around 'skin-gut axis' have been progressing, microbiome instrumental pathophysiology dermal conditions. The operates regulator immune system, facilitating bidirectional communication diverse tissues and organs sustain homeostasis. Dysbiosis, defined imbalance within microbiome, both skin gastrointestinal tract, significantly correlated aberrant responses recognised contributing factor onset eczema. In recent years, it has posited enteral strategies aimed modulating microbiomes could serve promising avenue for management prophylaxis diseases. Our studies (T-CHILD JECS) indicated relationship between antibiotic exposure disrupting gut incidence conditions, including [2] FPIES [3] general populations, suggesting enhancing microbiota equilibrium such prebiotics may play role prevention. However, specific advocated by existing guidelines currently lack robust empirical support. Notwithstanding, from scientific viewpoint, promotion balanced highly plausible exert effects against development Prebiotics are compounds remain unaltered unabsorbed proximal functioning substrates intestinal preservation health. Grüber et al. [4] demonstrated formulation incorporating oligosaccharides time birth mitigate Nonetheless, 2017, Cuello-Garcia [5] published comprehensive systematic review assessing prophylactic impact on eczema, which revealed no statistically significant variations. showed overall effect was reduction risk when compared control group, although confidence interval did not exclude null (RR, 0.68; 95% CI, 0.40–1.15; 2030 participants; six trials). Among array prebiotics, our investigation concentrated specifically kestose. Kestose classified trisaccharides, comprising combination sucrose fructose via β-1,1-glycosidic linkage. resistant digestion. ingested orally, kestose transported lower tract without being digested [6]. It selectively utilised microbiota. shown enhance proliferation butyrate-producing bacterial strains (Faecalibacterium prausnitzii) [7], elevating butyrate concentrations. Butyrate anticipated facilitate differentiation regulatory T cells (Tregs) manifestations. Shibata [8] reported findings regarding therapeutic efficacy context involving 30 children below age three diagnosed intervention group daily over 12-week period, whereas consumed maltose. Post-intervention, SCORAD score registered 19.5 37.5 maltose signifying amelioration (p < 0.001). As milk allergy children, enhanced relative abundance Faecalibacterium species modestly increased dose cow's tolerated [9]. there exists dearth prior examining preventative We undertaking double-blind, randomised, two-group parallel comparison study kestose, prebiotic, high-risk contrasting intake (Kestose Intake prevention atopic dermatitis Tokyo; KITY Study) registration Japan Registry Clinical Trials (jRCT): ID: jRCTs031220020 (https://jrct.niph.go.jp/en-latest-detail/jRCTs031220020). does administer pregnant women (Figure 1). protocol this article's Online Repository 10.5281/zenodo.13905238. K.Y.-H., M.S.-A., Y.I. Y.O. conceived idea study. All authors contributed fix protocol. K.P. contributes statistics. T.K. advised procedure. M.S.-A. drafted original manuscript. K.T., H.O. D.H. recruited followed participants. Y.H., H.M. K.M. handled blood samples. T.F., K.Y.-H. supervised conduct reviewed manuscript draft revised critically intellectual content. approved publication final version Ms. Miwako Seike Mariko Noda developed data plan Dr. Mayumi Sako, Nozomi Fukui Tomoko Matsushita monitoring Kozue Miyake, Yuki Saito, Junko Ikeda, Saki Ueno, Saya Kitami, Yukie Miyata, Mr. Sora Nazuka, Sayuri Tateai, Kazuko Hayase, Takako Kimura, Nishimura, Kumiko Watabe Emiko Matsuzaka supported research based Japanese Act (Act No. 16 14 April 2017) described website (https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000213334.pdf). Certified Review Board National Center Child Health Development February 24, 2022 (Reference number: CRB3200005). trial (https://jrct.niph.go.jp/en-latest-detail/jRCTs031220020) 13, 2022. parents provided their written consent participation before we enrolled trial. conducted collaborative project funded Natural Science Co. Ltd. involved certain aspects (such provision delivery test sugar, sugar cosmetics participants) preparing presentation materials assisting writing conference presentations). they analysis results. There conflict interest planning, implementation, interpretation or results would affect rights interests principal investigator manages following Conflict Interest Management Guidance under submitted standard Research approval. Each researcher appropriately any conflicts related standards plans discloses them required academic conferences medical journals presented. support available request corresponding author. publicly due privacy ethical restrictions.

Language: Английский

Citations

0