Rut Anne Thomassen, Janne Anita Kvammen, Beint S Bentsen, Marianne Bratlie, Siv Kjølsrud Bøhn, Hanne Farstad, Christian Kahrs, Linh Ngo, Camilla Nybø, Camilla Sæland, Erling Tjora, Rune Rose Tronstad, Ketil Størdal, Anne Charlotte Brun, Christine Henriksen
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In Phase 2, participants were randomised to either continue supplementation or cease supplementation for 6 months to evaluate long-term effects. Primary end points included parent-reported GI symptoms and HRQOL, measured by PedsQL™ scales. Secondary end points were stool consistency and frequency, nutritional support and antibiotic use.</p><p><strong>Results: </strong>Out of 47 children completing Phase 1, 43 completed Phase 2 (24 in the intervention group, 19 in the control group). After 4 weeks, 60% reported reduced GI symptoms. By the end of Phase 2, the intervention group showed no significant changes in HRQOL score, but significant GI symptom improvements compared to controls (mean paediatric quality of life inventory GI score difference of 6.9, p = 0.01). Stool frequency decreased (median -1.0 vs. 0 stools/day, p = 0.003), and stool consistency normalised more frequently in the intervention group (42% vs. 6%, p = 0.02). No significant changes were noted in nutritional support or antibiotic use.</p><p><strong>Conclusion: </strong>While HRQOL remained unchanged, short- and long-term prebiotic supplementation significantly improved GI symptoms, stool frequency and stool consistency in children with IF, indicating its potential as a therapeutic option in paediatric IF.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov ID: NCT04981262 https://clinicaltrials.gov/study/NCT04981262?cond=intestinal%20failure&term=prebiotics&rank=2.</p>","PeriodicalId":16694,"journal":{"name":"Journal of Pediatric Gastroenterology and Nutrition","volume":" ","pages":"975-985"},"PeriodicalIF":2.6000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12484718/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of prebiotics on gastrointestinal symptoms and quality of life in children with intestinal failure: A pilot study.\",\"authors\":\"Rut Anne Thomassen, Janne Anita Kvammen, Beint S Bentsen, Marianne Bratlie, Siv Kjølsrud Bøhn, Hanne Farstad, Christian Kahrs, Linh Ngo, Camilla Nybø, Camilla Sæland, Erling Tjora, Rune Rose Tronstad, Ketil Størdal, Anne Charlotte Brun, Christine Henriksen\",\"doi\":\"10.1002/jpn3.70186\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>Children with intestinal failure (IF) have a substantial disease burden, with significant gastrointestinal (GI) symptoms, abnormal stool patterns and reduced health-related quality of life (HRQOL). 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引用次数: 0
摘要
目的:肠功能衰竭(IF)患儿具有严重的疾病负担,伴有明显的胃肠道(GI)症状、粪便形态异常和健康相关生活质量(HRQOL)降低。本研究考察了益生元补充对胃肠道症状和HRQOL的影响。方法:一项开放标签、随机对照试验,包括两个阶段。在第一阶段,1-18岁的IF患儿接受了为期4周的益生元混合补充剂。在第二阶段,参与者被随机分为继续补充或停止补充6个月,以评估长期效果。主要终点包括父母报告的胃肠道症状和通过PedsQL™量表测量的HRQOL。次要终点是大便一致性和频率,营养支持和抗生素使用。结果:完成第1期治疗的47例患儿中,完成第2期治疗的43例(干预组24例,对照组19例)。4周后,60%的患者报告胃肠道症状减轻。到第2期结束时,干预组HRQOL评分无明显变化,但胃肠道症状较对照组有明显改善(儿童生活质量量表GI评分平均差异为6.9,p = 0.01)。大便频率下降(中位数为-1.0次vs. 0次/天,p = 0.003),干预组大便一致性更频繁地恢复正常(42% vs. 6%, p = 0.02)。在营养支持或抗生素的使用方面没有明显的变化。结论:在HRQOL保持不变的情况下,短期和长期益生元补充可显著改善儿童IF的胃肠道症状、大便频率和大便一致性,表明其作为儿科IF的治疗选择的潜力。试验注册:ClinicalTrials.gov ID: NCT04981262 https://clinicaltrials.gov/study/NCT04981262?cond=intestinal%20failure&term=prebiotics&rank=2。
Effect of prebiotics on gastrointestinal symptoms and quality of life in children with intestinal failure: A pilot study.
Objectives: Children with intestinal failure (IF) have a substantial disease burden, with significant gastrointestinal (GI) symptoms, abnormal stool patterns and reduced health-related quality of life (HRQOL). This study examined the effects of prebiotic supplementation on GI symptoms and HRQOL.
Methods: An open-label, randomised controlled trial involving two phases. In Phase 1, children aged 1-18 years with IF received supplementation with a blend of prebiotics for 4 weeks. In Phase 2, participants were randomised to either continue supplementation or cease supplementation for 6 months to evaluate long-term effects. Primary end points included parent-reported GI symptoms and HRQOL, measured by PedsQL™ scales. Secondary end points were stool consistency and frequency, nutritional support and antibiotic use.
Results: Out of 47 children completing Phase 1, 43 completed Phase 2 (24 in the intervention group, 19 in the control group). After 4 weeks, 60% reported reduced GI symptoms. By the end of Phase 2, the intervention group showed no significant changes in HRQOL score, but significant GI symptom improvements compared to controls (mean paediatric quality of life inventory GI score difference of 6.9, p = 0.01). Stool frequency decreased (median -1.0 vs. 0 stools/day, p = 0.003), and stool consistency normalised more frequently in the intervention group (42% vs. 6%, p = 0.02). No significant changes were noted in nutritional support or antibiotic use.
Conclusion: While HRQOL remained unchanged, short- and long-term prebiotic supplementation significantly improved GI symptoms, stool frequency and stool consistency in children with IF, indicating its potential as a therapeutic option in paediatric IF.
期刊介绍:
The Journal of Pediatric Gastroenterology and Nutrition (JPGN) provides a forum for original papers and reviews dealing with pediatric gastroenterology and nutrition, including normal and abnormal functions of the alimentary tract and its associated organs, including the salivary glands, pancreas, gallbladder, and liver. Particular emphasis is on development and its relation to infant and childhood nutrition.