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Article

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

1
The Institute of Reproductive and Child Health/Ministry of Health Key Laboratory of Reproductive Health, Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing 100191, China
2
Nestlé Product Technology Center-Nutrition, 1800 Vevey, Switzerland
3
Huantai Maternal and Child Health Care Hospital, Zibo 256400, China
4
Nestlé (China) Ltd., Beijing 100102, China
5
Center for Intelligent Public Health, Institute for Artificial Intelligence, Peking University, Beijing 100191, China
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editors: Giovanni Di Nardo and Iain A. Brownlee
Received: 2 September 2021 / Revised: 17 September 2021 / Accepted: 21 September 2021 / Published: 25 September 2021
(This article belongs to the Section Nutrition and Public Health)
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 View Full-Text
Keywords: partially hydrolyzed formula; low lactose; probiotics; mild gastrointestinal disorders; infant gastrointestinal symptom questionnaire; trials partially hydrolyzed formula; low lactose; probiotics; mild gastrointestinal disorders; infant gastrointestinal symptom questionnaire; trials
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MDPI and ACS Style

Huang, Y.; Zhou, Y.; Li, H.; Chen, Y.; Mu, Y.; Yuan, A.; Yang, Y.; Liu, J. The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. Nutrients 2021, 13, 3371. https://0-doi-org.brum.beds.ac.uk/10.3390/nu13103371

AMA Style

Huang Y, Zhou Y, Li H, Chen Y, Mu Y, Yuan A, Yang Y, Liu J. The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial. Nutrients. 2021; 13(10):3371. https://0-doi-org.brum.beds.ac.uk/10.3390/nu13103371

Chicago/Turabian Style

Huang, Yongying, Yubo Zhou, Hongtian Li, Yipu Chen, Yingchao Mu, Anan Yuan, Yantao Yang, and Jianmeng Liu. 2021. "The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial" Nutrients 13, no. 10: 3371. https://0-doi-org.brum.beds.ac.uk/10.3390/nu13103371

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