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

Abstract

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.

Keywords: colic; gastrointestinal tolerance; infant; infant formula; nutrition; probiotics.

Figure 1

Adjusted mean IGSQ composite scores ± SE by feeding groups. Group comparison done by analysis of covariance adjusted for feeding group, study site, infant age, sex, delivery type, history of GI disease in parents and mother’s education. IGSQ composite score can range from 13–65, with higher values indicating greater discomfort. Dotted line marks threshold of 23 indicating certain GI discomfort (>23 to 30; >30 to 65 indicates GI distress) and essentially no GI issues (≤23). BFI—Breastfed infants; FFI + LR—Infants fed formula with L. reuteri; FFI-Std—Infants fed standard formula without any probiotic or prebiotic; GI, gastrointestinal; IGSQ, Infant Gastrointestinal Symptom Questionnaire. n = 760 in BFI; n = 501 in FFI-Std; n = 470 in FFI + LR.

Figure 2

Comparisons of stool characteristics between the feeding groups, including mean differences for stool consistency (a) and odds ratios for difficulty passing stool (b). The vertical line shows the reference value for each measure. Stool consistency and difficulty in passing stool were measured using the Feeding Practice and Gut Comfort Questionnaire, which collected consistency for each stool and number of stools difficult to pass in the 24 h prior to the administration of the questionnaire. Stool consistency was measured using a 4-point scale (1 = Watery, 2 = Loose, 3 = Formed, 4 = Hard). Stool consistency was modeled using ANCOVA and difficulty passing stool was modeled using logistic regression. In addition to feeding group, models were further adjusted for study site (only for stool consistency), infant age, sex, delivery type, history of gastrointestinal disease in parents and mother’s education. BFI—Breastfed infants; FFI + LR—Infants fed formula with L. reuteri; FFI-Std—Infants fed standard formula without any probiotic or prebiotic. n = 760 in BFI; n = 501 in FFI-Std; n = 470 in FFI + LR.

Figure 3

Odds ratios with 95% confidence interval comparing physician-reported colic between feeding groups. The vertical line shows the reference value for the odds ratios. Physician-reported colic was measured using the Feeding Practice and Gut Comfort Questionnaire (“Was your child ever diagnosed with colic?” and “Did the child have colic in the past week?”). Both outcomes were modeled using logistic regression and adjusted for study site, infant age, sex, delivery type, history of gastrointestinal disease in parents and mother’s education. BFI—Breastfed infants; FFI + LR—Infants fed formula with L. reuteri; FFI-Std—Infants fed standard formula without any probiotic or prebiotic. n = 760 in BFI; n = 501 in FFI-Std; n = 470 in FFI + LR. (a) Physician-reported colic-colic in the past week; (b)Physician-reported colic-ever diagnosed with colic.