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Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational
, Luca Lavalle1, Nicolas Sauvageot1
1Biostatistics & Data, Nestlé Research, Lausanne, Switzerland.
Insights
Formula-fed infants show similar gastrointestinal tolerance to breastfed infants. Formulas with pre- and/or probiotics improve tolerance and reduce colic in formula-fed infants compared to those without these additions.
Area of Science:
- Pediatrics
- Gastroenterology
- Infant Nutrition
Background:
- Gastrointestinal (GI) symptoms are common in formula-fed infants (FFI).
- Observational studies are needed to assess GI tolerance in real-world settings.
- Comparing FFI with breastfed infants (BFI) and different formula types is crucial.
Purpose of the Study:
- To compare GI tolerance between formula-fed infants (FFI) and breastfed infants (BFI).
- To evaluate the impact of pre- and/or probiotics in formula on GI tolerance.
- To assess differences in GI symptoms, stooling, and colic among FFI and BFI.
Main Methods:
- A six-country, cross-sectional study involving 2036 FFI and 760 BFI aged 6-16 weeks.
- Validated questionnaires (IGSQ, Feeding Practice and Gut Comfort) were used.
- Infants were categorized into FFI with pre- and/or probiotics (FFI_PP), FFI without (FFI_noPP), and BFI.
Main Results:
- FFI demonstrated non-inferior overall GI tolerance compared to BFI (IGSQ scores < 23).
- FFI_PP showed similar GI tolerance (IGSQ 22.1) to BFI (22.3), while FFI_noPP had higher scores (23.4).
- FFI_PP had improved stooling, less crying, and fewer colic episodes than FFI_noPP, similar to BFI.
Conclusions:
- Formula-fed infants exhibit comparable overall GI tolerance to breastfed infants.
- Formulas supplemented with pre- and/or probiotics enhance GI comfort and reduce colic in FFI.
- Pre- and/or probiotics in formula lead to GI tolerance outcomes similar to those observed in breastfed infants.
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 ).
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