The aim of the present study is therefore to investigate the bifidogenic effect of a hypoallergenic formula (based on partially hydrolysed whey protein) supplemented with a specific combination of prebiotics and probiotics (synbiotics) compared to…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate a bifidogenic effect of a (HP synbiotics) compared to standard
infant formula in infants at high risk of developing allergy.
Secondary 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.
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.
Although allergic disorders have a hereditary element, the gene-environmental
interaction is clearly important in explaining the rapid increase over the last
decades. Knowing that the intestinal microbiome can significantly influence
human physiology, the early colonization process is thought to form a crucial
process laying the foundation for optimal health later in life. There is
increasing evidence that modifications in the pattern of microbial exposure
early in life represents a critical factor underlying the development of an
allergic phenotype. The role of the unbalanced endogenous microbiota in
developing allergy is supported by the positive correlation of environmental
factors that both impact the early microbial colonization process and the risk
to develop allergic disorders (i.e. antibiotic use and caesarean section), as
well as correlations of allergic disorders with an altered infant microbiome
and increasing evidence of successful prevention or reduction of allergy
through nutritional concepts that modulate the gut microbiota.
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.
The PATCH study (n=1047) performed by Nutricia Research, demonstrated that the
gut microbiota composition and activity of infants at increased risk of allergy
receiving the partially hydrolysed cow*s milk protein formula supplemented with
oligosaccharides was more similar to breastfed infants than to infants
receiving standard cow*s milk formula, which was driven by increased levels of
bifidobacteria. These observations may imply that microbial succession of
species and metabolite cross-feeding at specific developmental stages in early
life are essential in establishing a balanced gut community and environment
that supports gut development, but also homeostasis with our immune system
thereby having the potency to reduce the risk of allergy development.
Study objective
The aim of the present study is therefore to investigate the bifidogenic effect
of a hypoallergenic formula (based on partially hydrolysed whey protein)
supplemented with a specific combination of prebiotics and probiotics
(synbiotics) compared to standard infant formula in infants at high risk of
developing allergic disease. This study will secondary assess the effects of
this HA concept on the development of allergic manifestations up to the age of
12 months, which will be verified in a separate clinical study MAESTRO as
primary outcome. Furthermore, the effects on growth and safety will be studied.
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 breastfeeding group. For the active
formula group, there is a closely monitored event where if the doctor suspects
septicaemia, the intake of formula will be stopped and blood test will be
performed to find the origin of the infection. For the active formula and
control formula, the overall interaction with food as stated on the label will
be expected. 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, soy 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
randomization, except from consumption during the first 72 hours of life., 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 and/or intrmuscular
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 | NCT03067714 |
| CCMO | NL59111.072.16 |