Georgieva Miglena, Manios Yannis, Rasheva Niya, Pancheva Ruzha, Dimitrova Elena, Schaafsma Anne
Miglena Georgieva, Niya Rasheva, Elena Dimitrova, Second Pediatric Clinic, University Hospital "St. Marine", 9000 Varna, Bulgaria.
World J Clin Pediatr. 2016 Feb 8;5(1):118-27. doi: 10.5409/wjcp.v5.i1.118.
To examine the effect of carob-bean gum (CBG) thickened-formulas on reflux and tolerance indices in infants with gastro-esophageal reflux (GER).
Fifty-six eligible infants (1-6 mo old) were randomly allocated to receive for two weeks a formula with either 0.33 g/100 mL (Formula A) or 0.45 g/100 mL (Formula B) of cold soluble CBG galactomannans respectively, or a formula with 0.45 g/100 mL of hot soluble CBG galactomannans (Formula C). No control group receiving standard formula was included in the study. Data on the following indices were obtained both at baseline and follow-up from all study participants: 24 h esophageal pH monitoring indices, anthropometrical indices (i.e., body weight and length) and tolerance indices (i.e., frequency of colics; type and frequency of defecations). From the eligible infants, forty seven were included in an intention-to-treat analysis to examine the effects of the two-week trial on esophageal 24 h pH monitoring, growth and tolerance indices. Repeated Measures ANOVA was used to examine the research hypothesis.
Regarding changes in 24 h pH monitoring indices, significant decreases from baseline to follow-up were observed in the "Boix Ochoa Score" (i.e., an index of esophageal acid exposure), in the total number of visible refluxes and in all symptoms related indices due to acid reflux only for infants provided with Formula A, while no significant changes were observed for infants provided with Formulas B and C. In addition, the significant decreases observed in two symptoms related pH monitoring indices (i.e., "Symptom index for reflux" and "Percentage of all reflux") for infants provided with Formula A were also found to differentiate significantly compared to the changes observed in the other two groups (P = 0.048 and P = 0.014 respectively). Concerning changes in anthropometric indices, body weight significantly increased among infants provided with Formulas A and C, but not for infants provided with Formula B. As far as tolerance indices were concerned, the numbers of total and diarrheic defecations increased significantly only in infants provided with Formula B and these changes were significantly higher compared to the decreases observed in infants fed with Formulas A and C (P = 0.003 and P = 0.015 respectively. Lastly the number of colics significantly decreased in all infants, irrespective of the tested formula.
Formula A (i.e., 0.33 g/100 mL of cold galactomannans) was effective in reducing certain pH-monitoring indices of uncomplicated GER, increased body weight and was well-tolerated by infants.
探讨角豆树胶(CBG)增稠配方奶粉对胃食管反流(GER)婴儿反流及耐受性指标的影响。
56名符合条件的婴儿(1 - 6月龄)被随机分配,分别接受含0.33 g/100 mL(配方A)或0.45 g/100 mL(配方B)冷溶性CBG半乳甘露聚糖的配方奶粉两周,或含0.45 g/100 mL热溶性CBG半乳甘露聚糖的配方奶粉(配方C)两周。研究未设接受标准配方奶粉的对照组。在基线期和随访期从所有研究参与者处获取以下指标数据:24小时食管pH监测指标、人体测量指标(即体重和身长)以及耐受性指标(即肠绞痛频率;排便类型和频率)。在符合条件的婴儿中,47名纳入意向性分析,以检验为期两周的试验对食管24小时pH监测、生长和耐受性指标的影响。采用重复测量方差分析来检验研究假设。
关于24小时pH监测指标的变化,仅接受配方A的婴儿,从基线期到随访期,“博伊克斯·奥乔亚评分”(即食管酸暴露指数)、可见反流总数以及所有仅因酸反流引起的相关症状指标均显著下降,而接受配方B和配方C的婴儿未观察到显著变化。此外,接受配方A的婴儿在两个与症状相关的pH监测指标(即“反流症状指数”和“所有反流百分比”)上观察到的显著下降,与其他两组观察到的变化相比也有显著差异(分别为P = 0.048和P = 0.014)。关于人体测量指标的变化,接受配方A和配方C的婴儿体重显著增加,而接受配方B的婴儿体重未增加。就耐受性指标而言,仅接受配方B的婴儿总排便次数和腹泻排便次数显著增加,且这些变化与接受配方A和配方C喂养的婴儿所观察到的排便次数减少相比显著更高(分别为P = 0.003和P = 0.015)。最后,所有婴儿的肠绞痛次数均显著减少,无论所测试的配方奶粉如何。
配方A(即0.33 g/100 mL冷半乳甘露聚糖)在降低单纯性GER的某些pH监测指标、增加体重方面有效,且婴儿耐受性良好。