The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial

Yongying Huang, Yubo Zhou, Hongtian Li, Yipu Chen, Yingchao Mu, Anan Yuan, Yantao Yang, Jianmeng Liu, Yongying Huang, Yubo Zhou, Hongtian Li, Yipu Chen, Yingchao Mu, Anan Yuan, Yantao Yang, Jianmeng Liu

Abstract

Partially hydrolyzed formula (pHF) containing low lactose and probiotics may benefit the gastrointestinal health of infants. We aimed to assess the effects of pHF on mild gastrointestinal disorders (MGDs) of infants. In this single-armed trial, 80 full-term infants with MGDs were enrolled and fed a pHF for 14 consecutive days. The primary outcome resulted from the scores of gastrointestinal symptoms reported by parents using a validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) at Day 0 (baseline), Day 7, and Day 14. The total IGSQ scores ranged from 13 to 65. Higher scores indicated worse gastrointestinal symptoms. The IGSQ scores (mean ± SD) decreased from Day 0 (36.0 ± 5.7) to Day 7 (28.7 ± 7.4) and Day 14 (26.5 ± 8.1 (p < 0.001), with corresponding digestive distress prevalence (IGSQ score > 30) decreasing from 87.5% to 35.0% and 28.8% (p < 0.001). In the first three days, vomiting and flatulence scores decreased at Day 1 versus Day 0, and the crying score decreased at Day 2, but no significant changes were observed for fussy and stool characteristics. All growth parameters increased and no parents reported adverse events. In conclusion, feeding with a pHF containing low lactose and probiotics may comfort infants with MGDs, and the comforting effect likely manifests early in the first three days of the feeding interventions. Trial registration: ClinicalTrials.gov NCT04112056.

Keywords: infant gastrointestinal symptom questionnaire; low lactose; mild gastrointestinal disorders; partially hydrolyzed formula; probiotics; trials.

Conflict of interest statement

Yp Chen, Aa Yuan, and Yt Yang are employed by Nestlé, the sponsoring company; none of the other authors has a conflict of interest to disclose. The funders had no role in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Flow chart of enrolled infants.
Figure 2
Figure 2
Z-scores at Day 0 and Day 14 according to growth parameters. * p < 0.05.

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