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Effect of infant formula containing 40% whey protein hydrolysate on gastrointestinal comfort of infants

Effect of infant formula containing 40% whey protein hydrolysate on gastrointestinal comfort of infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053122
Enrollment
Unknown
Registered
2021-11-12
Start date
2023-06-20
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant growth and development

Interventions

Intervention group:Whey protein hydrolysate infant formula powder
Control group:Regular infant formula powder
Reference group:Breast feeding

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Formula powder feeding group: (1)Healthy infants whose mothers are unable or willing to give up breastfeeding completely; (2)Aged 80% until at least 4 months of age. 3.All infants: (1)Delivered between 37 and 42 weeks of gestation (2)Single or twin; (3)Birth weight >2500 g and <4000 g; (4)Parents or the subject's legal guardian are able to use and understand Chinese; (5)Normal pregnancy and delivery (infants delivered by cesarean section are matched); (6)Apgar score was higher than 7 at 5 and 10 minutes after birth; (7)Aged<=14 days at inclusion.

Exclusion criteria

Exclusion criteria: 1.Formula powder feeding group: (1)Infants fed formula mixed with breast milk for 14 days up to the date of recruitment. Exclusion criteria (breastfed group): 2.Breast-feeding group: (1)During feeding, formula powder accounted for more than 20% of the infants. 3.All infants: (1)Premature delivery (gestational age <=36+6 days); (2)Malformation, disability or congenital disease that may affect normal feeding or growth and development; (3)Use infant formula containing prebiotics or probiotics; (4)Use prebiotics or probiotics; (5)Known gastrointestinal organic disease; (6)Use of antibiotics (except nasal or eye topical drops); (7)Known milk allergy or other allergic diseases; (8)Participation in another intervention study or participation in other studies may influence the results of this study; (9)The researcher's parents or caregivers cannot meet the requirements of the research plan; (10)Newborn problems; (11)Other circumstances: 1)Frequent reflux, vomiting and "sudden coughing"; 2)Sandifer position; 3)Gastrointestinal bleeding; 4)Growth delay (weight gain <150g/w).

Design outcomes

Primary

MeasureTime frame
Questionnaire survey;General body measurement;Sample collection and testing;

Countries

China

Contacts

Public ContactZhang Yumei

School of Public Health, Peking University

zhangyumei@bjmu.edu.cn+86 134 2613 4251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026