Infants consuming the lactose free formula will grow in accordance to WHO growth standards and >80% will not present any intolerance symptoms
ID
Bron
Aandoening
Lactose intolerance
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Anthropometry: weight, length and head circumference
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Infants consuming the lactose free formula will grow in accordance to WHO growth standards and >80% will not present any intolerance symptoms
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Consumption of lactose free infant formula for 8 weeks
Publiek
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
Wetenschappelijk
I.M.S. Tan-Khouw
[default] 618818
Singapore
+65 6419 8474
ilse.tan-khouw@frieslandcampina.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4747 |
| NTR-old | NTR4875 |
| Ander register | : Nutr-MC-LacFree |