To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in vitro and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD…
ID
Source
Brief title
Condition
- Allergic conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary goal: Is there a decrease in severity of atopic dermatitis (AD) in
young children by daily supply of a multispecies probiotic mixture?
The primary outcome will be measured by change in the severity of AD by using
the SCORAD score.
Secondary outcomes: subjective (parental) change in eczema severity, change in
amount of and type of topical steroid use, quality of life during and after
intervention (measured by the validated ITQOL questionnaire), amount of
respiratory tract infections, use of antibiotics, use of primary care medicine
(general practitioner), change of microbiota composition, change in cytokine
pattern.
Secondary outcome
-Effects on infant gut microbiota
Analyses will be done by molecular microbiological techniques on feces samples
(that will be collected at baseline, and after 1,3 and 6 months after
enrollment.
-Effects on the immature immune system
These effects will be measured by analyzing serum IgE and different (Th1/Th2)
cytokines and chemokines
Background summary
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory
skin disease that often presents in infancy. The disease can be the first
manifestation of the so-called atopic march, the natural progression of
allergic disorders, with subsequent development of asthma and allergic
rhinitis. Approximately 40% of the children with AD will develop asthma later
in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic
dermatitis; however, relapses are common and parents often fear possible
side-effects, leading to non-compliance. There is increasing evidence that the
intestinal microbiota plays an important role in the development of allergic
diseases. Modulation of the intestinal microbiota with probiotics, living
micro-organisms with immunomodulatory effects, could possibly offer a new way
of treatment of allergic disease. Clinical trials investigating the therapeutic
effect of probiotics on atopic dermatitis show inconsistent results. A
systematic review of all these clinical trials concluded that the probiotic
strains studied to date are not an effective treatment for AD; however, other
strains might have a greater effect. So, better results can possibly be
achieved by using a selected, in vitro proven modulatory probiotic mixture,
containing 6 different strains.
Study objective
To investigate the therapeutic effect of a selected probiotic mixture on the
severity of AD in infants aged 0-15 months. The probiotic mixture has been
studied in vitro and has proven IL-10 stimulating effects. Therefore it is
thought to decrease AD severity in these young children.
Study design
Participants will be randomized, using computer-generated block design lists,
drawn up by a statistician, with stratification
according to serum IgE, to daily receive either a powder (sachets) with
additional probiotics or the same powder (sachets) without probiotics for a
period of 12 weeks.
Patients will be enrolled by the investigator (NR) and sequentially assigned a
patient number. Powders will be prepared and coded by Wilclove Bio Industries
BV, Amsterdam and dispensed by the pharmacy of St. Antonius Hospital. Both
formulas are identical with respect to smell, taste,
texture, color and packaging. The investigators (NR, AV), participant*s own
physicians and parents are all blind to the treatment groups. The randomization
key will be owned by the hospital*s pharmacy as well as the company that
produces the probiotics.
Intervention
One intervention arm, in which participants daily ingest an (in vitro designed
and proven effective modulatory) probiotic mixture for a period of 3 months;
compared to controls (in the other arm) that receive a placebo.
-Product name: Ecologic ® Panda II
-Probiotic strains: Bifidobacterium breve (W25), Bifidobacterium lactis (ATCC
SD 5219 en ATCC SD 5220), Lactobacillus plantarum (W62), Lactobacillus
salivarius (W57) and Lactococcus lactis (W19), 1*109 Colony Forming Units/g.
-Composition: rice starch, maltodextrines, potassium chloride, magnesium
sulphate, bacterial strains and manganese suphate.
The placebo mixture is similar in aspect, consistency and taste.
Study burden and risks
- The supply of probiotics to young children has been considered as safe in
general. All used strains contain the QPS status.
- All children have to endure blood samples twice. The first one is part of the
standard 'eczema treatment', while the second one is considered as additional
intervention. Nevertheless, the secong blood sample is important because of
determination of specific IgE and cyto- and chemokines before and after
(probiotic or placebo) intervention.
- Parents have to visit our hospital 4 times during the study, that is usual
frequency for children suffering from atopic dermatitis.
- The parents will be asked to update an included dairy weekly. They should
report eczema severity, nutrition pattern, periods of illness/infection,
medication use, and possible (serious) side effects.
You may also see paragraph 5 (Safety) and 7 (Ethical issues) of the (Dutch)
protocol.
Postbus 2500
3430 EM Nieuwegein
Nederland
Postbus 2500
3430 EM Nieuwegein
Nederland
Listed location countries
Age
Inclusion criteria
age 0-15 months
atopic dermatitis for at least 2 weeks, with SCORAD score 15-50
Exclusion criteria
class II or higher class topical corticosteroid use, or use of systemic corticosteroids
antibiotic treatment just before enrollment or in the first week of the study
syndromal abnormalities, major medical problems
lack of knowledge of the Dutch language
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 | NCT01230190 |
| CCMO | NL34163.100.10 |