The project is focused on induction of immune tolerance in allergy by prebiotics. The pathophysiology of immune modulation will be investigated and searched for potential biomarkers for immune modulation.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of infants who develop tolerance at each outpatient day clinic
visit (OPD), determined by a DBPCFC.
Secondary outcome
The incidence and severity of asthma and allergic rhinitis.
Serum Total IgE, IgG and IgG4 concentration.
Newly acquired sensitizations, measured by specific IgE for the most prevalent
food-and inhalant allergens.
Peripheral blood derived T-cell phenotype, antigen-specific proliferation and
cytokine production and/or expression of intracellular transcription factors
specific for regulatory T-cells and cytokine production.
Stool samples will be studied for identification and quantification of
micro-organisms.
Background summary
Inflammatory diseases like allergies and autoimmune diseases are increasing in
the Western world. These disorders are associated with a disturbed immune
balance and lack of immunological tolerance. Therefore there is a wide interest
in development of safe immune modulating therapies to correct for these
disorders.
Intervention in early life will focus on promotion of a proper maturation of
the immune system and prevention of inflammatory and autoimmune diseases. Later
in life, specific immunotherapy is the only curative treatment left. Current
knowledge indicates a key role for dendritic cells (DC) during initiation of
adaptive cellular immunity. Depending on several factors, DCs direct T cell
responses by either promoting T cell activation (Th1 or Th2 response) or by
inducing tolerance (activation of regulatory T cells).
Recently is shown that the gastro-intestinal tract is one of the most essential
factors for development of immune tolerance. Natural occurring candidates for
tolerance induction are heat shock proteins (HSP) and oligosaccharides.
Oligosaccharides and glycoproteins have demonstrated to promote Th1 activity
and suppress occurrence of allergies and infections. The exact mechanisms is
still not clear but a mixture of neutral galacto-oligosaccharides (GOS) and
fructo-oligosaccharides (FOS) have been identified as effective prebiotic
ingredients.
Study objective
The project is focused on induction of immune tolerance in allergy by
prebiotics. The pathophysiology of immune modulation will be investigated and
searched for potential biomarkers for immune modulation.
Study design
1. Double-blind, placebo-controlled, randomised trial with prebiotics in young
children with cow*s milk allergy.
2. In vitro evaluation of immunologic effects of prebiotics in these children
Intervention
Oligosaccharides and glycoproteins mixed with hydrolysed formula or breastmilk.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Risks and burden for subjects are considered
minimal and related to DBPCFC and blood withdrawals.
DBPCFC will be done during one of the OPD visits and under controlled
circumstances.
Blood withdrawal will be done by experienced professionals.
Vuursteenoever 14
3433 DE Nieuwegein
NL
Vuursteenoever 14
3433 DE Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
Child
Cow's milk allergy diagnosed by double blind, placebocontrolled randomised foodchallenge
Exclusion criteria
immune-mediated disease
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 |
|---|---|
| CCMO | NL16218.041.07 |