Infant Feeding Regimens and Gastrointestinal Tolerance: A Multicenter, Prospective, Observational Cohort Study in China

Mao, Meng; Zhang, Lan; Ge, John; Yan, Jian; Northington, Robert; Yao, Manjiang; Nowacki, Joyce; Hays, Nicholas P.

doi:10.1177/2333794x17750271

Cited by 10 publications

(6 citation statements)

References 57 publications

(77 reference statements)

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“…The average baseline IGSQ sum score of 36 in this study confirms findings from previous studies that regurgitation is frequently associated with other GI symptoms (11,12). IGSQ sum scores improved significantly within 1 week and after 4 weeks, scores were comparable to values reported in healthy term born infants without specific GI issues (23,27–31).…”

Section: Discussionsupporting

confidence: 88%

Safety and Tolerance of a Novel Anti‐Regurgitation Formula

Bellaïche

Ludwig

Arciszewska³

et al. 2021

J. pediatr. gastroenterol. nutr.

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Objectives: A novel anti-regurgitation (AR) formula has been designed to support gut health and improve gastrointestinal (GI) symptoms beyond regurgitation. This study assessed the tolerance and safety of this new AR formula. Methods: This was a 4-week double-blind, randomized, controlled trial with a 4-week extension in formula-fed infants with regurgitation. The new AR (Test) formula contained 0.4 g/100 mL locust bean gum (LBG) as thickener, partly fermented formula with postbiotics, and short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS) (0.4 g/100 mL, ratio 9:1). The Control AR formula contained LBG (0.4 g/100 mL) with postbiotics and has a history of safe use. The primary outcome was the Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum score including stooling, spitting-up/vomiting, crying, fussiness and flatulence. Results: All 182 infants screened were enrolled in the study. The primary analysis showed the equivalence of the IGSQ sum scores at Week 4 between groups. IGSQ sum scores improved significantly within 1 week (Mixed Model Repeated Measurement [MMRM], P < 0.001). Post-hoc analyses showed a bigger improvement of the IGSQ score in the Test (n = 38) versus Control (n = 44) group (MMRM, P = 0.008) in infants with more severe gastrointestinal (GI) symptoms (IGSQ score ≥35). Stool characteristics were comparable between groups. Growth related z scores were in line with the WHO child growth standards and both groups showed improvement of regurgitation. Adverse events did not show any safety concerns. Conclusions: The novel AR formula combining LBG, scGOS/lcFOS and postbiotics is well-tolerated, safe and supports adequate growth during the intervention. Post-hoc analyses suggest that the formula results in more improvement of GI symptom burden in infants with more severe symptoms.

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Section: Discussionsupporting

confidence: 88%

Safety and Tolerance of a Novel Anti‐Regurgitation Formula

Bellaïche

Ludwig

Arciszewska³

et al. 2021

J. pediatr. gastroenterol. nutr.

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“…Similarly, infants who switched to a formula containing L. reuteri and 2′fucosyllactose improved their IGSQ composite score from above 30 to 22.1 after receiving the L. reuteri -containing formula for 3 weeks [ 19 ]. Other studies conducted in the US and in China using the IGSQ to assess GI tolerance of formulas with optional ingredients reported lower composite scores [ 20 , 21 ]. Differences among studies might be explained by different effects of the various optional formula ingredients that were studied.…”

Section: Discussionmentioning

confidence: 99%

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

Consortium¹,

Lavalle

Sauvageot

et al. 2023

Nutrients

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Limosilactobacillus (L.; previously Lactobacillus) reuteri has been shown to influence gastrointestinal (GI) tolerance. This study was a secondary analysis of GI tolerance data from a multi-country, cross-sectional, observational study in healthy infants using the validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) and a gut comfort questionnaire. Breastfed infants (BFI; n = 760) were compared to formula-fed infants receiving either L. reuteri-containing formula (FFI + LR; n = 470) or standard formula without any probiotic or prebiotic (FFI-Std; n = 501). The IGSQ composite scores (adjusted mean ± SE) in FFI + LR (22.17 ± 0.39) was significantly lower than in FFI-Std (23.41 ± 0.37) and similar to BFI (22.34 ± 0.30;), indicating better GI tolerance in FFI + LR than in FFI-Std. Compared with FFI-Std, FFI + LR had lower reports of difficulty in passing stools (11% vs. 22%; adjusted-odds ratio (OR) (95%CI) = 0.46 (0.31–0.68)), fewer hard stools (mean difference = −0.12 (−0.21, −0.02)) and less physician-confirmed colic (OR = 0.61 (0.45–0.82)), and similar to BFI. Parent-reported crying time (mean difference = −0.15 (−0.28, −0.01)), frequency of spitting-up/vomiting (mean difference = −0.18 (−0.34, −0.03)), volume of spit-up (mean difference = −0.20 (−0.32, −0.08)) and fussiness due to spitting-up/vomiting (mean difference = −0.17 (−0.29, −0.05)) were lower in FFI + LR versus FFI-Std and similar to BFI. In this study, L. reuteri-containing formula was associated with improved digestive tolerance and behavioral patterns.

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“…Similarly, an interventional real-world evidence study in Spain found no difference in IGSQ scores after 8 weeks among infants receiving a formula with 2’fucosyllactose and lacto-n-neotetraose, infants receiving a mixture of formula and breastmilk, and exclusive BFI (mean IGSQ scores 20.7, 20.4, and 19.9, respectively) [ 18 ]. Another real-world study in China had similar IGSQ scores among infants receiving a formula with added sn-2 palmitate and oligofructose (sn-2 + OF), a mixture of sn-2 + OF formula and breastmilk, and breastmilk alone (mean IGSQ scores after 18 days were 17.5, 18.2, and 16.3, respectively) [ 19 ]. Collectively, these results, including the present study, demonstrate good GI tolerance for pre- and/or probiotic supplemented formulas comparable to that in BFI.…”

Section: Discussionmentioning

confidence: 99%

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

Jalaludin¹,

Taher²,

Kiau³

et al. 2022

BMC Pediatr

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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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Infant Feeding Regimens and Gastrointestinal Tolerance: A Multicenter, Prospective, Observational Cohort Study in China

Cited by 10 publications

References 57 publications

Safety and Tolerance of a Novel Anti‐Regurgitation Formula

Safety and Tolerance of a Novel Anti‐Regurgitation Formula

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

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

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