The breastfed infants also had softer stools, with significantly higher mean stool consistency scores at both 6 weeks postnatal (2.4, 1.9, and 1.9, respectively, p < 0.05) and 12 weeks postnatal (2.4, 2.0, and 2.0, respectively, p < 0.05).
However, significant differences in mean stool consistency were detected by day 30 and continued through day 180; more infants with a formed and fewer infants with an unformed or seedy stool consistency in the Control compared to the investigational formula groups were the primary differences.
The primary endpoint was average stool consistency in the last 2 weeks of treatment.
Mean rank stool consistency was softer in infants fed NoPALM versus PALM (p < 0.001; metabolic period).
In the tolerance phase, a sample size of 20 subjects per group has 80% power to detect a difference of at least 0.55 in mean rank stool consistency.
From previous studies 11 the estimated mean (SD) stool consistency in healthy controls was 3.6 (1.1) and recent unpublished data suggest a within-person correlation of 0.5.
The secondary variables included calcium retention, fat absorption, mean rank stool consistency (MRSC scored as 5 = watery, 4 = loose/mushy, 3 = soft, 2 = formed, 1 = hard), and average number of stools per day.
No group differences in mean (±SE) stool consistency (with categories corresponding to 1 = hard, 2 = formed, 3 = soft, 4 = unformed or seedy, 5 = watery; Table 4) were detected at baseline.
AAF: Amino Acid-Based Formula; CD: Chronic Diarrhea; CD-C: Chronic Diarrhea Study in Children; CD-I: Chronic Diarrhea Study in Infants; MRSC: Mean Rank Stool Consistency; PN: Parenteral Nutrition; SBS: Short Bowel Syndrome; SD: Study Day; WHO: World Health Organization.
Mean rank stool consistency (MRSC) was calculated from the parental ranking of each stool using a scale of 1 to 5 for CD-C (1 = runny, mostly liquid, 2 = soft, unformed, 3 = soft, formed, 4 = hard, formed, 5 = hard, dry) and a scale of 1 to 4 for CD-I (1 = watery, 2 = loose/mushy, 3 = soft, 4 = formed).
VF were associated with greater frequencies and intensities of abdominal distention (p < 0.001) and flatulence (p < 0.001), and greater frequency of stools (p < 0.001) compared to CH, but there were no differences in mean or maximum (loosest) stool consistency (p > 0.05).
