Gayatri Athalye-Jape, Meera Esvaran, Sanjay Patole, Elizabeth A Nathan, Dorota A Doherty, Edric Sim, Lakshmi Chandrasekaran, Chooi Kok, Stephan Schuster, Patricia Conway
{"title":"早产儿服用活益生菌与热灭活益生菌双歧杆菌的效果：随机临床试验。","authors":"Gayatri Athalye-Jape, Meera Esvaran, Sanjay Patole, Elizabeth A Nathan, Dorota A Doherty, Edric Sim, Lakshmi Chandrasekaran, Chooi Kok, Stephan Schuster, Patricia Conway","doi":"10.1136/archdischild-2023-326667","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Heat-inactivated probiotics (HPs) may provide an effective alternative to live probiotics (P) by avoiding their risks (eg, probiotic sepsis) while retaining the benefits. We assessed the safety and efficacy of a HP in very preterm (VP: gestation <32 weeks) infants.</p><p><strong>Methods: </strong>VP infants were randomly allocated to receive a HP or P mixture (<i>Bifidobacterium breve</i> M-16V, <i>Bifidobacterium longum</i> subsp. <i>infantis</i> M-63, <i>Bifidobacterium longum</i> subsp. <i>longum</i> BB536, total 3×10<sup>9 </sup>CFU/day) assuring blinding. Primary outcome was faecal calprotectin (FCP) levels were compared after 3 weeks of supplementation. Secondary outcomes included faecal microbiota and short chain fatty acid (SCFA) levels.</p><p><strong>Results: </strong>86 VP infants were randomised to HP or P group (n=43 each). Total FCP and SCFA were comparable between HP and P groups within 7 days (T1) and between day 21 and 28 (T2) after supplementation. At T2, median (range) FCP was 75 (8-563) in the HP group and 80 (21-277) in the P group (p=0.71). Propionate was significantly raised in both groups, while butyrate was significantly raised in the HP group (all p<0.01). Bacterial richness and diversity increased but was comparable between HP and P (p>0.05). Beta diversity showed similar community structures in both groups (all p>0.05). Changes in faecal Actinobacteria, Bacteroidetes and Bifidobacteriacae levels were comparable in both groups at T1 and T2. There was no probiotic sepsis.</p><p><strong>Conclusions: </strong>HP was safe and showed no significant difference in FCP as compared with a live probiotic. Adequately powered trials are needed to assess the effects of HP on clinically significant outcomes in preterm infants.</p><p><strong>Trial registration number: </strong>ACTRN12618000489291.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":null,"pages":null},"PeriodicalIF":3.9000,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of a live versus heat-inactivated probiotic <i>Bifidobacterium</i> spp in preterm infants: a randomised clinical trial.\",\"authors\":\"Gayatri Athalye-Jape, Meera Esvaran, Sanjay Patole, Elizabeth A Nathan, Dorota A Doherty, Edric Sim, Lakshmi Chandrasekaran, Chooi Kok, Stephan Schuster, Patricia Conway\",\"doi\":\"10.1136/archdischild-2023-326667\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Heat-inactivated probiotics (HPs) may provide an effective alternative to live probiotics (P) by avoiding their risks (eg, probiotic sepsis) while retaining the benefits. We assessed the safety and efficacy of a HP in very preterm (VP: gestation <32 weeks) infants.</p><p><strong>Methods: </strong>VP infants were randomly allocated to receive a HP or P mixture (<i>Bifidobacterium breve</i> M-16V, <i>Bifidobacterium longum</i> subsp. <i>infantis</i> M-63, <i>Bifidobacterium longum</i> subsp. <i>longum</i> BB536, total 3×10<sup>9 </sup>CFU/day) assuring blinding. Primary outcome was faecal calprotectin (FCP) levels were compared after 3 weeks of supplementation. Secondary outcomes included faecal microbiota and short chain fatty acid (SCFA) levels.</p><p><strong>Results: </strong>86 VP infants were randomised to HP or P group (n=43 each). Total FCP and SCFA were comparable between HP and P groups within 7 days (T1) and between day 21 and 28 (T2) after supplementation. At T2, median (range) FCP was 75 (8-563) in the HP group and 80 (21-277) in the P group (p=0.71). Propionate was significantly raised in both groups, while butyrate was significantly raised in the HP group (all p<0.01). Bacterial richness and diversity increased but was comparable between HP and P (p>0.05). Beta diversity showed similar community structures in both groups (all p>0.05). Changes in faecal Actinobacteria, Bacteroidetes and Bifidobacteriacae levels were comparable in both groups at T1 and T2. There was no probiotic sepsis.</p><p><strong>Conclusions: </strong>HP was safe and showed no significant difference in FCP as compared with a live probiotic. Adequately powered trials are needed to assess the effects of HP on clinically significant outcomes in preterm infants.</p><p><strong>Trial registration number: </strong>ACTRN12618000489291.</p>\",\"PeriodicalId\":8177,\"journal\":{\"name\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-08-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/archdischild-2023-326667\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Disease in Childhood - Fetal and Neonatal Edition","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/archdischild-2023-326667","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
Effects of a live versus heat-inactivated probiotic Bifidobacterium spp in preterm infants: a randomised clinical trial.
Background: Heat-inactivated probiotics (HPs) may provide an effective alternative to live probiotics (P) by avoiding their risks (eg, probiotic sepsis) while retaining the benefits. We assessed the safety and efficacy of a HP in very preterm (VP: gestation <32 weeks) infants.
Methods: VP infants were randomly allocated to receive a HP or P mixture (Bifidobacterium breve M-16V, Bifidobacterium longum subsp. infantis M-63, Bifidobacterium longum subsp. longum BB536, total 3×109 CFU/day) assuring blinding. Primary outcome was faecal calprotectin (FCP) levels were compared after 3 weeks of supplementation. Secondary outcomes included faecal microbiota and short chain fatty acid (SCFA) levels.
Results: 86 VP infants were randomised to HP or P group (n=43 each). Total FCP and SCFA were comparable between HP and P groups within 7 days (T1) and between day 21 and 28 (T2) after supplementation. At T2, median (range) FCP was 75 (8-563) in the HP group and 80 (21-277) in the P group (p=0.71). Propionate was significantly raised in both groups, while butyrate was significantly raised in the HP group (all p<0.01). Bacterial richness and diversity increased but was comparable between HP and P (p>0.05). Beta diversity showed similar community structures in both groups (all p>0.05). Changes in faecal Actinobacteria, Bacteroidetes and Bifidobacteriacae levels were comparable in both groups at T1 and T2. There was no probiotic sepsis.
Conclusions: HP was safe and showed no significant difference in FCP as compared with a live probiotic. Adequately powered trials are needed to assess the effects of HP on clinically significant outcomes in preterm infants.
期刊介绍：
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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