This study investigates the preventive action of formula with partially hydrolysed cow milk protein supplemented with pre- and probiotics in the development of allergy. The goal of the study is to investigate the efficacy, the growth and the safety…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study investigates the effect of HP synbiotics compared to standard infant
formula on the development of allergic manifestations up to the age of 12
months in infants at high risk of developing allergy.
The primary outcome parameter will be chosen based on the results of an
independent study (TEMPO). The choice will be implemented during the interim
analysis (see protocol section 10) and documented in an administrative protocol
amendment.
Secondary outcome
To investigate the effect of HP synbiotics compared to standard infant formula
on the development of growth, safety, allergic manifestations (immune and/or
microbiota parameters in faeces, blood and saliva) up to the age of 12 months
in infants at high risk of developing allergy.
Background summary
Over the past decades, the prevalence of allergic disorders has increased
exponentially around the world with variation in physical location of the
manifestation (skin, lung, GI tract) dependent on geographical spread. With the
increased prevalence of allergic disease and the deriving risk of the
development of other immune related diseases, primary prevention from allergies
has become an important priority. Many studies have been conducted to
investigate and develop primary prevention from allergies using nutrition in
children with a high risk of developing allergic disease.
It is generally acknowledged that breastfeeding is one of the main pillars in
allergy prevention. Many studies have examined the benefits of breastfeeding on
the development of allergic disease. From these studies, it can be concluded
that breastfeeding up to 4-6 months decreases the risk of atopic dermatitis in
infants at increased risk. When a mother is unable or chooses not to breastfeed
her infant, an infant formula based on the composition of human milk is
recognized as the best alternative. For infants at increased risk to develop
allergy a partially hydrolysed cow*s milk protein formula is developed.
A German and Australian study and a study conducted by Nutricia Research
(PATCH), which investigated the use of hydrolysed formula, show a minor short
term effect beside a long term decrease of allergic disease in children with a
high risk. However eczema and food allergies are the most common allergic
manifestations in the first 2 years, eczema turns out to be more of an
indicative risk factor for allergic sensitization due to a changed skin barrier
than a symptom of allergy. Therefor additional studies in children with a high
risk of developing allergic disease is needed, to confirm the possible effects
of pHF on the reduction of allergic symptoms.
Study objective
This study investigates the preventive action of formula with partially
hydrolysed cow milk protein supplemented with pre- and probiotics in the
development of allergy. The goal of the study is to investigate the efficacy,
the growth and the safety of the hypo allergen formula in children whom can
develop allergy or allergic manifestations in the first 52 weeks of their life
compared to normal formula.
Study design
This is a randomised, double blind, controlled, parallel-group, multi-country
study.
Intervention
Active product: Formula /follow-up formula with partially hydrolysed whey
protein supplemented with prebiotics and probiotics (HP synbiotics)
Control product: standard formula/follow-up formula (complete protein)
Study burden and risks
No adverse events are expected in the active formula/ follow-up formula (HP
synbiotics) or control formula/follow-up formula, except the expected overall
interaction with food as stated on the label. The use of probiotics is
associated with softer stools (where it looks more like the stools of breastfed
infants). The test product contains cow milk proteins. These proteins can cause
an allergic reaction in children with a cow milk, soya protein, cow meat, corn
or fish protein allergy. The taking of a blood sample can give mild pain, cause
a bruise, an inflammation of the vein, hemorrhage or infection of the place
where the needle has gone into the skin and rarely can cause nerve damage.
Taking a nasal swab may cause temporary discomfort. Filling in the diary will
cost extra time for parents. The skin prick test can cause discomfort and mild
red skin and itching of the skin punctured specify which usually disappears
within hours.
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
Inclusion criteria
1) Healthy term infants (gestational age * 37 and * 42 weeks) at high risk of
developing allergy based on family history of allergy.;2) Infants aged * 16 weeks (max. 16 weeks + 0 days), preferably as soon as
possible after birth.;3) Infants with birth weight within normal range for gestational age and sex (10th
to 90th percentile according to local applicable growth charts).;4) Infants who start formula feeding within 16 weeks of age (infants of mothers
who have chosen not to breastfeed or mothers who completely/partially
cease breastfeeding before the subject*s age of 16 weeks)
OR
Infants who are exclusively breastfed and whose mothers have the
intention to exclusively breastfeed at least until their infant is 16 weeks of
age.;5) Written informed consent from one or both parents (according to local
laws) and/or legal guardian.
Exclusion criteria
1) Consumption of any amount of infant formula based on intact protein before
randomisation.;2) Consumption of any amount of infant formula with added probiotics and/or
probiotic supplement before randomisation.;3) Existing allergic manifestations (e.g. allergic skin disorders, food allergy)
before randomisation according to investigator*s clinical assessment.;4) Severe congenital abnormalities which could influence the subjects* growth
(e.g. cystic fibrosis, bronchopulmonary dysplasia, tracheomalacia,
tracheoesophageal fistula, major congenital heart disease, or any other
condition according to investigator's clinical judgement).;5) Severe neonatal illnesses (e.g. respiratory distress syndrome, severe sepsis
intraventricular hemorrhage, severe neonatal jaundice, necrotizing enterocolitis, persistent pulmonary hypertension of the newborn, or any other
condition which required the use of intravenous antibiotic).;6) Known underlying disease predisposing to infection (e.g. HIV, viral hepatitis
B, and C, auto-immune diabetes, immune deficiency).;7) Severe renal failure and hepatic failure according to investigator's clinical
judgement.;8) Incapability of the parents to comply with study protocol or investigator's
uncertainty about the willingness or ability of the subject to comply with the
protocol requirements;9) Participation in other studies involving investigational or marketed products
concomitantly or within two weeks prior to screening visit.
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 |
|---|---|
| ClinicalTrials.gov | NCT03062995 |
| CCMO | NL59596.072.16 |