To study the immunomodulatory effects of non-digestible oligosaccharides using peripheral blood mononucleated cells isolated from blood of healthy controls and patients with peanut or cow*s milk allergy.
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The T-cell response (measured by cytokine production) and phenotype of these
cells (Th1/Th2/Treg by flow cytometry) in patients before and after stimulation
of their isolated cells from blood with specific allergen (whey or peanut) and
the influence and effect of NDOs on this response (with/without presence of
artificial CpG DNA or Bifidobacterium breve DNA)
Secondary outcome
Changes in cytokine and chemokine profile of PBMCs after stimulation with NDOs
will be studied. Also changes in cytokine and proliferation within
subpopulations of the PBMCs will be studied (e.g. Dendritic cells or T-cells)
and the interaction between these groups. To study safety of the NDOs, the
activation of basophils will also be monitored.
Background summary
Food allergy is an important socio-economic problem which is estimated to occur
in 2-3% of the population. Current treatment encompasses symptomatic treatment
and elimination diets. Human studies have shown encouraging results when
treating subjects with subcutaneous or oral administration of allergy-related
proteins. However, adverse effects are not uncommon and these forms of
immunotherapy have not yet resulted in sustained unresponsiveness. Recent in
vitro studies, as well as studies in children and mice have indicated that a
mixture of dietary non-digestible oligosaccharides (NDOs) either or not
together with immune polarizing adjuvants like bacterial CpG DNA may improve
the efficacy and safety of immunotherapy in allergic patients.
Study objective
To study the immunomodulatory effects of non-digestible oligosaccharides using
peripheral blood mononucleated cells isolated from blood of healthy controls
and patients with peanut or cow*s milk allergy.
Study design
Subjects will be asked questions about their allergic history by the researcher
and recent usage of corticosteroids and antihistamine prior to blood withdrawal
of a variable amount of 60-100 mL. A sample of blood will be taken from a vein
in the arm (venepuncture). The technique for obtaining blood frequently
involves the use of various-sized vacuum tubes specific for collecting blood.
Clinical investigators will collect 60-100 mL blood from adults. The blood will
be processed by the PhD student as soon as possible for laboratory tests.
Study burden and risks
The most common side effect is a small discoloration or bruise that may remain
at the site for several days. There may be mild temporary pain associated with
insertion of the needle. In very rare cases, a local infection may occur at
the site of the venipuncture. The subject will be informed that there may be
some slight pain and discomfort with the blood withdrawal.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Patients with established cow*s milk or peanut allergy (determined by food provocation) in the age of 18-65 years from our outpatient clinic Allergology/Dermatology
Exclusion criteria
Pregnancy and use of systemic immunosuppressants (the continuous use, not local usage as an effect of an allergic reaction, e.g. prednison)
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 | NL51606.041.15 |