Abstract：
Pharmacological intervention with laxatives is the conventional treatment for functional constipation (FC). Data to support the dietary management of FC is lacking. This study compared the efficacy of two Comfort young child formulas (YCFs) with regards to the maintenance of healthy stooling parameters in toddlers with a history of constipation. It was registered in the Netherlands Trial Registry [identifier: NL7420 (NTR7653)], registration date 20/09/2018.
Ninety-five healthy toddlers, aged 12 to 32 months, diagnosed with FC (Rome III criteria) were randomized to receive one of two study formulas after pharmacological treatment. For the first month of the intervention, subjects received a laxative in a decreasing maintenance dose alongside a test or control formula (maintenance phase). Subsequently, subjects only consumed formula for another month (post-maintenance phase). Stooling parameters were obtained weekly using the Bristol Stool Scale and the modified Rome III Questionnaire on Paediatric Gastrointestinal Symptoms for infants and toddlers. Differences in percentages of hard stools (primary outcome) and other stooling parameters were analysed using analysis of covariance and Chi-Square methods.
Both formulas resulted in similar overall percentage of hard stools during the intervention period, respectively 5.02% in the test and 2.99% in the control group (n.s.). In the test group, percentages dropped from 7.11% at the end of the maintenance phase, to 3.92% at the end of the post-maintenance phase. In contrast, the percentage of hard stools in the control group was similar at the end of the maintenance (3.18%) and post-maintenance phase (2.83%; n.s.). No difference was found in the overall stool frequency between groups. At the end of the maintenance phase, only 22% and 19% of toddlers consuming the test and control formulae, respectively, met 2 or more of the criteria for FC. At the end of the study, this percentage of subjects decreased further to 9% in the test group, which tended to be lower compared to the 21% found in the control (p = 0.107). No laxative use was reported in either study group during the post-maintenance phase.
Both Comfort YCF support the maintenance of improved stooling over time in toddlers with a history of constipation. The percentage of subjects suffering from functional constipation tended to be lower after the intervention period when receiving the formula with intact protein.
Ninety-five healthy toddlers, aged 12 to 32 months, diagnosed with FC (Rome III criteria) were randomized to receive one of two study formulas after pharmacological treatment. For the first month of the intervention, subjects received a laxative in a decreasing maintenance dose alongside a test or control formula (maintenance phase). Subsequently, subjects only consumed formula for another month (post-maintenance phase). Stooling parameters were obtained weekly using the Bristol Stool Scale and the modified Rome III Questionnaire on Paediatric Gastrointestinal Symptoms for infants and toddlers. Differences in percentages of hard stools (primary outcome) and other stooling parameters were analysed using analysis of covariance and Chi-Square methods.
Both formulas resulted in similar overall percentage of hard stools during the intervention period, respectively 5.02% in the test and 2.99% in the control group (n.s.). In the test group, percentages dropped from 7.11% at the end of the maintenance phase, to 3.92% at the end of the post-maintenance phase. In contrast, the percentage of hard stools in the control group was similar at the end of the maintenance (3.18%) and post-maintenance phase (2.83%; n.s.). No difference was found in the overall stool frequency between groups. At the end of the maintenance phase, only 22% and 19% of toddlers consuming the test and control formulae, respectively, met 2 or more of the criteria for FC. At the end of the study, this percentage of subjects decreased further to 9% in the test group, which tended to be lower compared to the 21% found in the control (p = 0.107). No laxative use was reported in either study group during the post-maintenance phase.
Both Comfort YCF support the maintenance of improved stooling over time in toddlers with a history of constipation. The percentage of subjects suffering from functional constipation tended to be lower after the intervention period when receiving the formula with intact protein.
摘要：
泻药的药物干预是功能性便秘（FC）的常规治疗方法。缺乏支持FC饮食管理的数据。这项研究比较了两种舒适幼儿配方（YCFs）在维持有便秘史的幼儿健康便参数方面的功效。它在荷兰审判登记处注册[标识符：NL7420(NTR7653)]，注册日期20/09/2018。
95个健康的幼儿，12至32个月，诊断为FC(罗马III标准)的患者在药物治疗后随机接受两种研究配方中的一种.在干预的第一个月，受试者接受了减少维持剂量的泻药以及测试或对照配方（维持阶段）。随后，受试者仅在另一个月内消耗配方奶粉(维护后阶段)。每周使用布里斯托尔粪便量表和改良的罗马III问卷对婴幼儿的小儿胃肠道症状进行统计。使用协方差分析和卡方方法分析了硬大便百分比（主要结果）和其他大便参数的差异。
在干预期间，两种配方都导致了相似的硬大便总百分比，试验组分别为5.02%,对照组为2.99%(n.s.)。在测试组中，百分比从维护阶段结束时的7.11%下降，至维护后阶段结束时的3.92%。相比之下,对照组的硬便百分比在维持结束时(3.18%)和维持后阶段(2.83%;n.s.)相似.两组之间的整体粪便频率没有差异。在维护阶段结束时，只有22%和19%的幼儿使用测试和对照配方，分别,符合FC的2个或更多标准。在研究结束时,在测试组中，这一比例进一步下降到9%，与对照组中的21%相比，这往往较低(p=0.107)。在维持后阶段，任一研究组均未报告使用泻药。
两种ComfortYCF都支持在有便秘史的幼儿中随着时间的推移保持改善的大便。当接受具有完整蛋白质的配方时,患有功能性便秘的受试者的百分比在干预期后趋于更低。
95个健康的幼儿，12至32个月，诊断为FC(罗马III标准)的患者在药物治疗后随机接受两种研究配方中的一种.在干预的第一个月，受试者接受了减少维持剂量的泻药以及测试或对照配方（维持阶段）。随后，受试者仅在另一个月内消耗配方奶粉(维护后阶段)。每周使用布里斯托尔粪便量表和改良的罗马III问卷对婴幼儿的小儿胃肠道症状进行统计。使用协方差分析和卡方方法分析了硬大便百分比（主要结果）和其他大便参数的差异。
在干预期间，两种配方都导致了相似的硬大便总百分比，试验组分别为5.02%,对照组为2.99%(n.s.)。在测试组中，百分比从维护阶段结束时的7.11%下降，至维护后阶段结束时的3.92%。相比之下,对照组的硬便百分比在维持结束时(3.18%)和维持后阶段(2.83%;n.s.)相似.两组之间的整体粪便频率没有差异。在维护阶段结束时，只有22%和19%的幼儿使用测试和对照配方，分别,符合FC的2个或更多标准。在研究结束时,在测试组中，这一比例进一步下降到9%，与对照组中的21%相比，这往往较低(p=0.107)。在维持后阶段，任一研究组均未报告使用泻药。
两种ComfortYCF都支持在有便秘史的幼儿中随着时间的推移保持改善的大便。当接受具有完整蛋白质的配方时,患有功能性便秘的受试者的百分比在干预期后趋于更低。
