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Acceptance test for lactose free infant formula


- candidate number20851
- NTR NumberNTR4875
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2014
- Secondary IDsNutr-MC-LacFree 
- Public TitleAcceptance test for lactose free infant formula
- Scientific TitleAcceptance test for lactose free infant formula
- ACRONYM
- hypothesisInfants consuming the lactose free formula will grow in accordance to WHO growth standards and >80% will not present any intolerance symptoms
- Healt Condition(s) or Problem(s) studiedLactose intolerance
- Inclusion criteriaFull 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 criteriaExclusively 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-dec-2014
- planned closingdate1-mei-2015
- Target number of participants36
- InterventionsConsumption of lactose free infant formula for 8 weeks
- Primary outcomeAnthropometry: weight, length and head circumference
- Secondary outcomeTolerance: regurgitation, colic, dyschezia, constipation, vomiting
- Timepointst=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
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES I.M.S. Tan-Khouw
- CONTACT for SCIENTIFIC QUERIES I.M.S. Tan-Khouw
- Sponsor/Initiator FrieslandCampina
- Funding
(Source(s) of Monetary or Material Support)
FrieslandCampina
- Publications
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD3-nov-2014 - 16-dec-2014


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