Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study

Abstract

Background Signs of feeding intolerance, such as gastrointestinal (GI) symptoms, are frequently observed in otherwise healthy formula-fed infants in the first months of life. The primary objective of this observational study was to examine GI tolerance in formula-fed infants (FFI) vs. breastfed infants (BFI) in a real-world setting with a secondary objective being the comparison of infants fed formula with pre- and/or probiotics (FFI_PP) and those fed formula without any pre- and/or probiotics (FFI_noPP) as well as BFI. Methods A six-country, cross-sectional study in full-term exclusively/predominantly FFI (n = 2036) and BFI (n = 760) aged 6–16 weeks was conducted using the validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) and a Feeding Practice and Gut Comfort Questionnaire. Results The IGSQ composite 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) and scores for BFI and FFI were below the threshold of 23, indicating no GI discomfort. Adjusted mean IGSQ scores ± SE were similar in FFI_PP (22.1 ± 0.2) and BFI (22.3 ± 0.3) while FFI_noPP (23.4 ± 0.3) was significantly higher and above 23 indicating some GI discomfort (mean differences [95%CI] FFI_noPP minus FFI_PP and FFI_noPP minus BFI were 1.28 [0.57, 1.98] and 1.09 [0.38, 1.80], respectively; both p < 0.01). Hard stools and difficulty in passing stool were more common in FFI compared to BFI (p < 0.01) but were less common in FFI_PP compared to FFI_noPP (p < 0.01). FFI_PP showed significantly less crying than FFI_noPP and was similar to BFI. Significantly fewer physician-confirmed colic episodes (Rome IV criteria) were reported in FFI_PP compared with FFI_noPP or BFI. Conclusions In this real-world observational study, FFI had non-inferior overall GI tolerance compared to BFI. Within FFI, infants receiving formulas with pre- and/or probiotics had a better GI tolerance, improved stooling and less infantile colic compared to those receiving formula without any pre- and/or probiotics and were more similar to BFI. Trial registration NCT03703583, 12/10/2018 (https://clinicaltrials.gov/ct2/show/NCT03703583).

Limosilactobacillus reuteri DSM 17938-Containing Infant Formulas and the Associations with Gastrointestinal Tolerance: A Cross-Sectional Observational Study

“…A previously reported observational study found that GI tolerance was improved in infants who received formula containing any prebiotics or probiotics or a combination thereof compared with infants receiving formula that did not contain these ingredients [ 14 ]. The current secondary analysis of the same observational study provides interesting complementary data for one specific probiotic that has often been associated with GI tolerance.…”

“…L. reuteri DSM 17938 has been examined in relation to multiple outcomes in clinical studies of infants [ 12 ]. However, most of the available data is for L. reuteri supplements in breastfed infants and real-world effectiveness data has only been published for infant formula combining L. reuteri and prebiotics [ 38 ] or for infant formula containing any pre- and/or probiotics [ 14 ] but not L. reuteri alone. Thus, the key strength of this study is its novelty providing the first large-scale real-world effectiveness data for one specific probiotic, L. reuteri DSM 17938, as part of a formula matrix covering a broad spectrum of endpoints including GI tolerance, stooling pattern and colic prevalence.…”

“…Analyses were conducted using SAS/STAT software version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). This current analysis reports the secondary analysis of data from a cross-sectional observational study (ClinicalTrials.gov: NCT03703583) [ 14 ]; hence, no sample size calculation is available.…”

“…Therefore, understanding the effectiveness of L. reuteri -containing formula in real-world settings is important as it provides complementary evidence to the findings from controlled trial settings, but such data are not currently available. In a large cross-sectional observational study, GI tolerance of infants who received formula containing any prebiotics or probiotics or a combination was non-inferior to breastfed infants [ 14 ]. In addition, these infants had better GI outcomes than infants who had received formula without the addition of any prebiotics or probiotics.…”