The Safety and Efficacy of Bovine Milk-Delivered Oligosaccharides (MOS) Infant Formula

The Safety and Efficacy of Bovine Milk-Delivered Oligosaccharides (MOS) Infant Formula in Growth Velocity and Stool Consistency
Student's Name
Institutional Affiliation
Instructor
Date
The FDA rule on good manufacturing practices for baby formula requires the composition to satisfy the biological quality of protein and age-appropriate factors for growth. WHO and UNICEF advocate for absolute breastfeeding without solid or liquid complements for the first six months and an introduction of safe and nutritional food complements after six months of continuous breastfeeding. On the other hand, many mothers, especially of low birth weight infants, experience insufficient breast milk production, leading them to choose baby formula. Human Milk Oligosaccharides modulate the immune response, enhance cognition through the gut-brain axis, promote a balanced gut microbiota, and reduce infections. The paper will investigate several questions, such as what the problem is and how prevalent it is. Why is it a problem, and what is known and unknown about the situation? The problem in the chosen study is difficulties in passing stool and inconsistent growth patterns associated with baby formula.
The study by Estorninos et al. is the first study investigating how infant formula containing bovine milk supplements supports age-appropriate growth and reduces infant stooling difficulties. The impact of the study is to examine the health, safety, and effectiveness of a MOS-supplemented infant formula enriched with 7.2g/l of Bovine Milk-Delivered Oligosaccharides (Estorninos et al., 2022). The infant formula also incorporates sn-2 palmitate and lactalbumin. According to the authors, a practical approach to incorporating an oligosaccharide component in infant formula to make it equal to breast milk is by enriching it with MOS. Bovine milk is similar to breast milk because it contains low galactooligosaccharides and sialylated oligosaccharides. Therefore, adding MOS to infant formula reduced the difficulties of passing stool for infants by promoting softer stool patterns. The study concludes that bovine milk supplements in baby formula are safe and effective in promoting softer stooling patterns and supporting age-appropriate growth. At the same time, MOS-supplemented baby formula reduced parent-reported and physician-confirmed critical infant health concerns.
The methodology used by the authors is enrolling infants for the study according to the WHO child growth standards. Using a dynamic allocation algorithm, the authors enrolled the participants from Asian Hospital and Medical Centre in 2016-2017. They were 21-26 days and had a gestation period of 37-42 weeks (Estorninos et al., 2022). The primary consideration was infants whose parents considered baby formula before the trial. The participants who met the study criteria were randomly selected and enrolled to receive either control or test formula for the examination for six months. The requirement for the trial is that the infants must be fed bovine milk formula upon enrollment.
On the other hand, exclusion criteria included a family history that could alter the trial results, supplements suspected to modify stool characteristics and growth, parents suspected of not complying with the trial protocol, and feeding children with foods and fluids before enrollment. In this regard, incorporating milk whey, alpha-lactalbumin, and MOS supplement accounted for the control formula. The test infant formula was similar to the control trial, which also incorporated MOS bovine milk at a concentration of 7.2g/l.
According to Estorninos et al., healthcare providers conducted trial clinic visits upon recruitment at 21-26 days, six months, 1.5 months, four months, and 2.4 months (Estorninos et al., 2022). The visits involved collecting anthropometric measures, medical history, and healthcare workers performing clinical examinations. The study's primary outcomes were stool consistency and growth velocity. Parents reported stool consistency during clinic visits based on the infant's stool frequency as either watery, mushy soft, runny, rigid, or formed using standardized stool photographs. The trial's secondary outcomes include GI tolerance indicators, other anthropometry measurements without clothing on a calibrated electronic scale, and formula intake. The authors used the R foundation of statis...