Discussion
diarrhea, watery diarrhea, watery, diarrheal, diarrheagenic
In our randomized double-blind placebo-controlled parallel trial we aimed to evaluate the efficacy of Fibersol-2 along with ORS treatment to reduce the duration of watery diarrhea and stool output in children of 1–3 years as well as recovery of children within 72 hours where no beneficial role of Fibersol-2 was seen in reducing the outcomes, compared to placebo. The mean duration of resolution of diarrhea from the enrollment was comparable between placebo and Fibersol-2. All of the study participants recovered from watery stool within 7-day intervention period in the study. We do not have any ready reference to explain such a result other than relatively small sample size that caused reduced power of the study. There was the longer trend of diarrheal duration on enrollment observed in study children received Fibersol-2 compared to placebo. Interestingly, the result showed that the diarrheal duration on enrollment and the duration to recover from diarrhea were very similar for both groups. Therefore, the differences in diarrhea duration between groups on enrollment may have affected the outcomes, and the effectiveness of Fibersol-2 was not shown in the present study.It is our speculation that the environmental changes such as climate change, home environment, household pets, the use of non-sanitary facility may affect the duration of diarrheal improvement. But as our study is a randomized controlled trial, the effects of environmental changes should be upon both group of children and it might not cause any change in the overall outcome of the study.Slow fermentation pattern in large intestine is one of characteristics of Fibersol-2 among various fermentable soluble dietary fibers. A study conducted in humans showed slower fermentation rate of Fibersol-2 compared to other soluble non digestible carbohydrates such as fructo oligosaccharides, guar gum, and PHGG [One of the major limitations of this study was accuracy in collecting stool from the female children. Despite several strict attempts to measure the stool volume accurately, mixing of urine particularly in case of female children with the stool by chance might have taken place which made the stool amount more than actual. Moreover, the study did not examine the presence of bacterial or viral diarrheagenic pathogens, thus, the study failed to identify the etiologic differentials in diarrheal duration and stool output. Potential inflation of a type I error may occur as a result of multiple testing of subgroup comparisons, treatment arms, outcomes and analyses of the same outcome at different times. This can be prevented by complete and accurate reporting of the analyses being outlined in the registered trial protocols and mitigated by various statistical adjustment methods.