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Can bovine colostrum added to infant formula prevent diarrheal and respiratory diseases?

The role of bovine colostrum as prophylaxis for respiratory infections and diarrhea in formula feeding infants after birth

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87866805
Enrollment
192
Registered
2018-12-20
Start date
2017-08-01
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Infants fully formula feeding after birth Infections and Infestations Infants fully formula feeding after birth

Interventions

Eligible infants were randomly assigned to one of the two intervention groups. Infants in the intervention group (IG) were given a commercially available bovine colostrum (BC) sachet (Hainan Govking H

Sponsors

Chengdu Women's and Children's Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Apparent good health without common obstetric risk factors 2. Full term with 37-42 weeks’ gestation at birth with birth weight of more than 2500 g 3. Previously fully formula feeding after birth to 6-9 months at recruitment 4. Parent or guardian approval for participating in all aspects of the study 5. Parent or guardian agreement to avoid additional BC and probiotic products during the investigation

Exclusion criteria

Exclusion criteria: 1. History of severe, persistent, or chronic diarrhea 2. Severe malnutrition 3. Serious infections requiring hospitalization in the month prior 4. Serious chronic illness 5. Personal or family history of allergy to cow’s milk or intact infant formula 6. Eczema 7. Allergic rhinitis 8. Asthma

Design outcomes

Primary

MeasureTime frame
The following are assessed using patient interviews throughout the 3 month intervention period: 1. Morbidity of diarrhea 2. Respiratory tract infections

Secondary

MeasureTime frame
The following are assessed at the baseline and after 3 months: 1. Duration of respiratory-related illnesses, assessed using patient interviews 2. Duration of diarrhea-related illnesses, assessed using patient interviews 3. Growth levels of infants, assessed by measuring their weight, length and head circumference 4. Family functional scores assessed using PedsQL™ 2.0 Family Impact Module 5. Levels of the following, assessed using ELISA of fecal samples: 5.1. IgA 5.2. Calprotectin 5.3. Total fatty acid

Countries

China

Outcome results

None listed

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