Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial
dc.contributor.author | Fabrizio, Veronica | |
dc.contributor.author | Harris, Cheryl L. | |
dc.contributor.author | Walsh, Kelly R. | |
dc.contributor.author | Wampler, Jennifer L. | |
dc.contributor.author | Zhuang, Weihong | |
dc.contributor.author | Wu, Steven S. | |
dc.contributor.department | Pediatrics, School of Medicine | en_US |
dc.date.accessioned | 2023-07-10T17:27:08Z | |
dc.date.available | 2023-07-10T17:27:08Z | |
dc.date.issued | 2022-05-31 | |
dc.description.abstract | Objective: To evaluate stool consistency in infants with reported hard or infrequent stools fed hydrolyzed protein formula with added prebiotics designed to promote stool softening. Methods: In this multi-center, double-blind, controlled study, eligible infants (28-300 days of age at enrollment) were randomized to: partially hydrolyzed cow's milk protein formula (PHF, 75% carbohydrate as lactose; 12 mg Mg/100 kcal; n = 49) or routine intact protein cow's milk-based infant formula (Control, 92% carbohydrate as lactose; 8 mg Mg/100 kcal; n = 51) over a 14-day period. Both formulas had a prebiotic blend (polydextrose and galactooligosaccharides, 4 g/L; 1:1 ratio). Parent-reported stool consistency (hard = 1 through watery = 5) and other daily outcomes were collected by diary. Endpoint stool consistency (mean score over last 3 days of study feeding) was the primary outcome. Adverse events were recorded. Results: Baseline stool consistency (Control: 1.4 ± 0.1, PHF: 1.4 ± 0.1) and frequency were similar between groups; the majority had hard (n = 61, 64%) or formed (n = 30, 32%) stools. Stool consistency became softer over Day 1-3 (Control: 2.5 ± 0.1, PHF: 2.6 ± 0.1) and remained similar from Day 4 to 6 through study end (post hoc analysis). For PHF vs Control, endpoint stool consistency was significantly softer (3.4 ± 0.1 vs 3.0 ± 0.1; P = 0.019) and frequency significantly higher (1.5 ± 0.1 vs 1.0 ± 0.1; P = 0.002). Crying, fussing, and appearance of pain during stooling decreased from baseline to study end in both groups. Formula intake, infant fussiness and incidence of adverse events were similar between groups. Conclusion: An infant formula designed to promote stool softening was well-tolerated and associated with softer, more frequent stools in infants with reported hard or infrequent stools. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Fabrizio V, Harris CL, Walsh KR, Wampler JL, Zhuang W, Wu SS. Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial. Front Pediatr. 2022;10:894626. Published 2022 May 31. doi:10.3389/fped.2022.894626 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/34297 | |
dc.language.iso | en_US | en_US |
dc.publisher | Frontiers Media | en_US |
dc.relation.isversionof | 10.3389/fped.2022.894626 | en_US |
dc.relation.journal | Frontiers in Pediatrics | en_US |
dc.rights | Attribution 4.0 International | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.source | PMC | en_US |
dc.subject | Galactooligosaccharides (GOS) | en_US |
dc.subject | Infant feeding | en_US |
dc.subject | Infant formula | en_US |
dc.subject | Polydextrose | en_US |
dc.subject | Tolerance | en_US |
dc.title | Softer More Frequent Stools in Infants With Difficult Stooling Fed Hydrolyzed Protein Formula With Added Prebiotics: Randomized Controlled Trial | en_US |
dc.type | Article | en_US |