富含低聚果糖的菊粉补充剂对无麸质饮食的小儿乳糜泻患者肠道微生物群、营养状况和胃肠道症状的影响：一项前瞻性随机对照试验研究方案。
The effect of oligofructose-enriched inulin supplementation on gut microbiota, nutritional status and gastrointestinal symptoms in paediatric coeliac disease patients on a gluten-free diet: study protocol for a pilot randomized controlled trial.
机构信息
Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, Tuwima 10 Str, 10-748, Olsztyn, Poland.
Department of Clinical Pediatrics, Faculty of Medical Science, University of Warmia & Mazury, Oczapowskiego 2, Str, 10-719, Olsztyn, Poland.
出版信息
Nutr J. 2017 Aug 22;16(1):47. doi: 10.1186/s12937-017-0268-z.
BACKGROUND
A lifelong gluten-free diet (GFD) is regarded as the only proven and accepted therapy for coeliac disease (CD). However, even patients who strictly follow a GFD often suffer from intestinal symptoms and malabsorption. Selective modulation of intestinal microbiota with prebiotics could remedy various symptoms associated with CD. The use of prebiotics in the treatment of intestinal diseases remains insufficiently investigated. To our knowledge, this study makes the first attempt to evaluate the effect of prebiotic supplementation on gastrointestinal symptoms and nutritional status of children with CD. We hypothesized that adherence to a GFD supplemented with oligofructose-enriched inulin (Synergy 1) would deliver health benefits to children suffering from CD without any side effects, and that it would alleviate intestinal inflammation, restore and stabilize gut microbial balance and reverse nutritional deficiencies through enhanced absorption of vitamins and minerals.
METHODS
A randomized, placebo-controlled clinical trial was designed to assess the impact of the Synergy 1 on paediatric CD patients following a GFD. We randomized 34 children diagnosed with CD into an intervention group receiving 10 g of the Synergy 1 supplement daily and a placebo group (receiving maltodextrin) during a 12-week nutritional intervention. Selected biochemical parameters, nutritional status and the characteristics of faecal bacteria will be determined in samples collected before and after the intervention. Analysis of vitamins and amino acids concentration in biological fluids will allow to assess the dietary intake of crucial nutrients. The compliance to a GFD will be confirmed by a Food Frequency Questionnaire (FFQ-6) and the analysis of serum anti-tissue transglutaminase and faecal gluten immunogenic peptides (GIP).
CONCLUSION
The identification of the beneficial effects of the Synergy 1 supplement on children with CD could have important implications for nutritional recommendations for CD patients and for alleviating the harmful effects of the disease.
TRIAL REGISTRATION
ClinicalTrials.gov Registration Number: NCT03064997 .
背景
终生无麸质饮食（GFD）被认为是治疗乳糜泻（CD）的唯一有效且被认可的疗法。然而，即使是严格遵循 GFD 的患者，也常常会出现肠道症状和吸收不良。通过使用益生元选择性地调节肠道微生物群，可能可以改善与 CD 相关的各种症状。在治疗肠道疾病方面，益生元的应用研究还不够充分。据我们所知，本研究首次尝试评估补充益生元对 CD 患儿胃肠道症状和营养状况的影响。我们假设，在遵循 GFD 的基础上补充富含低聚果糖的菊粉（Synergy 1），可以为患有 CD 的儿童带来健康益处，且无任何副作用，同时可以减轻肠道炎症，通过增强维生素和矿物质的吸收来恢复和稳定肠道微生物平衡并纠正营养缺乏。
方法
我们设计了一项随机、安慰剂对照临床试验，以评估 Synergy 1 对遵循 GFD 的小儿 CD 患者的影响。我们将 34 名确诊为 CD 的儿童随机分为干预组（每天接受 10 克 Synergy 1 补充剂）和安慰剂组（接受麦芽糊精），进行为期 12 周的营养干预。在干预前后采集样本，以确定选定的生化参数、营养状况和粪便细菌特征。分析生物体液中维生素和氨基酸的浓度，可评估关键营养素的饮食摄入量。通过食物频率问卷（FFQ-6）和血清抗组织转谷氨酰胺酶和粪便麸质免疫原性肽（GIP）分析来确认对 GFD 的依从性。
结论
如果确定了 Synergy 1 补充剂对 CD 患儿的有益作用，这可能对 CD 患者的营养建议以及减轻疾病的有害影响具有重要意义。
试验注册
ClinicalTrials.gov 注册号：NCT03064997。
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