No registrations found.
ID
Source
Health condition
Lactose intolerance
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anthropometry: weight, length and head circumference
Secondary outcome
Tolerance: regurgitation, colic, dyschezia, constipation, vomiting
Background summary
A new lactose free infant formula has been developed. Before introducing the product in the market an acceptance test will be carries out to collect safety data.
Apparently healthy infants will consume the study formula for a period of 8 weeks. Anthropometric data and tolerance information will be collected. The hypothesis is that healthy children consuming this lactose free formula will grow in accordance to WHO standards and will tolerate the formula well.
Study objective
Infants consuming the lactose free formula will grow in accordance to WHO growth standards and >80% will not present any intolerance symptoms
Study design
t=0: baseline visit: anthropometry, inclusion questionnaire, tolerance questionnaire, crying diary
t=4 weeks: 2nd visit: anthropometry, crying diary, tolerance questionnaire
t=8 weeks: 3rd and last visit: anthropometry, crying diary, tolerance questionnaire
Intervention
Consumption of lactose free infant formula for 8 weeks
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
Inclusion criteria
Full term infants (both males and females) aged 1-4 months)
Infants who are already consuming exclusively regular infant formula for at least two weeks and who tolerate the formula well
Signed informed consent by parents/legal guardians
Parents/legal guardians having the ability to write and read and having the willingness to fulfil all the details of the protocol
No known cow's milk allergy with infant not parents/ siblings
Exclusion criteria
Exclusively breastfeeding at the time of inclusion
Consuming any food for special medical purposes
Gestational age less than 37 weeks
Birth weight less than 2500 grams
Growth parameters at the time of inclusion not in accordance with WHO standards
Feeding problems
Intolerance to infant formula before entering the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4747 |
| NTR-old | NTR4875 |
| Other | : Nutr-MC-LacFree |