Originally published by 2 Minute Medicine® (view original article). Reused on AccessMedicine with permission.

1. In healthy, full-term infants aged 6 to 16 weeks, formula fed infants have non-inferior gastrointestinal (GI) tolerance compared to breast fed infants

2. Formula-fed infants receiving formulas with pre-and/or probiotics had better GI tolerance than those fed without any pre-and/or probiotics

Evidence Rating Level: 2 (Good)

Study Rundown:

Feeding intolerance is often seen in healthy term formula-fed infants (FFI), manifested as gastrointestinal (GI) symptoms and behavioural concerns. Breastfed infants (BFI) are found to have a lower prevalence of some problems such as colic, flatulence and regurgitation, and also have different compositions of stool, with more frequent and softer stools than FFI. Previous randomized control trials have also found the addition of pre-and/or probiotics to infant formulas have improved GI tolerance, but these studies were limited to certain geographic areas. With many parents switching infant formulations for various reasons including vomiting, regurgitation and adjustment behaviours, the concern around GI intolerance is high. Understanding benefits of various compositions of formulas may positively impact GI tolerance symptoms and behaviours for FFI. This retrospective cohort study examined full-term infants from India, Malaysia, Indonesia, Egypt, Pakistan and the Philippines, and aimed to examine GI tolerance in FFI and BFI in a real-world setting, while also comparing formula-fed infants with pre-and/or probiotics (FFI_PP) and those without any pre-and/or probiotics (FFI_noPP). Researchers found that FFI had non-inferior overall GI tolerance compared to BFI. Also, those who received formula with pre-and/or probiotics had improved stooling and less colic than those fed with formula that did not contain pre-and/or probiotics. Overall, this provides evidence of the potential benefits of pre-and/or probiotics in FFI.

In-Depth [retrospective cohort study]:

This cross-sectional observational study included participants from 6 different countries: India, Malaysia, Indonesia, Egypt, Pakistan and the Philippines. Eligible infants were healthy, born full term, between 6-16 weeks of age and were either exclusively/predominantly breastfed or exclusively/predominantly formula fed. Those who had 75% or more of daily feeds for at least the last two weeks from breast milk were assigned to BFI and those who had 75% or more of daily feeds for at least the last two weeks from formula milk were assigned FFI. The FFI group was then broken into two subgroups, those fed a formula containing pre and/or probiotics (FFI_PP) or a formula not containing any pre-and/or probiotics (FFI_noPP). Overall, 2036 FFI and 760 BFI were included in the study, with 1500 FFI_PP infants and 501 FFI_noPP infants. GI tolerance was assessed using Infant Gastrointestinal Symptom Questionnaire (IGSQ) and the Feeding Practice and Gut Comfort Questionnaire (FPGCQ) was used to assess stool frequency and consistency, difficulty passing stool and physician confirmed colic. The IGSQ is a questionnaire with scores ranging from 13-65, with higher scores indicating greater discomfort. The FPGCQ collected information on feeding practices (counts of breasts and formula feeds per day and formula brand), colic (defined using the ROME IV criteria) and 24-hour stool characteristics (rated from 1-4, with 1-watery and 4-hard). The composite IGSQ score in FFI was non-inferior compared to BFI ((mean difference [95%CI]: 0.17 [-0.34, 0.67]; non-inferiority p-value < 0.0001) but both scores were below the threshold of 23, which indicates no GI discomfort. Once adjusted for covariants such as feeding regime, study site, infant age, sex, delivery type, family history GI disease and maternal education, the FFI_noPP group (23.4 ± 0.3) showed significantly higher scores, above the threshold of 23 compared to FFI_PP (22.1 ± 0.2) and BFI (22.3 ± 0.3). This indicates some discomfort in the group that was formula fed with no pre-and/or probiotics. In the FFI group, hard stools and difficulty passing stool were more common compared to BFI, (p < 0.01). Within the FFI group, hard stools and difficulty passing stools were less common in FFI_PP (p < 0.01). Finally, significantly fewer colic episodes were seen in FFI_PP than both other groups. This study shows that infants receiving pre and or probiotics may have GI benefits such as better GI tolerance, improved stooling and less colic compared to those who do not receive pre-and or probiotics.

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