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Study citation taken from Emerson Ecologics email:
Probiotics for the Treatment of Children with Atopic Dermatitis
Reference:
Rosenfeldt V, Benfeldt E, Nielsen S, et al. Effect of probiotic Lactobacillus strains in children with atopic dermatitis.
J Allergy Clin Immunol 2003;111:389-95.
Design:
Randomized, double-blind, placebo-controlled, crossover trial.
Participants:
Forty-three male and female patients (mean age 5.1 years; age range 1-13 years) with atopic dermatitis (AD).
Study Medication and Dosage:
Subjects were randomized to receive either a combination of Lactobacillus rhamnosus 19070-2 and Lactobacillus reuteri
DSM 12246 (containing 1 X 1010 colony forming units [CFUs] of each strain per dose) or placebo, dissolved in liquid, two times
per day for six weeks. After a six-week washout period, subjects received crossover treatment for six weeks. L. rhamnosus
and L. reuteri were manufactured by Chr. Hansen A/S (Hørsholm, Denmark).
Duration:
Twenty weeks
Outcome Measures:
Data on allergic sensitization were obtained from results of a skin prick test (SPT). The severity of AD was evaluated
at baseline (two weeks before intervention) and at the end of each treatment period. A standardized scoring system (scoring
atopic dermatitis [SCORAD]) developed by the European Task Force for Atopic Dermatitis was used. The SCORAD combines the clinical
evaluation of intensity and extent of AD with a subjective itch score indicated by patient, parents or both on a visual analog
scale. The range of the SCORAD is 0 to 80. AD was graded as mild (0-15), moderate (16-40), or severe (> 40). In addition,
the patients were asked at each visit whether they believed their AD to be generally better, unchanged, or worse during the
last intervention period. Before the intervention periods, blood was drawn for serum IgE (sIgE), and at the end of each intervention,
blood samples were drawn for Eosinophilic Cationic Protein (ECP) and production of cytokines was measured from PBMCs.
Key Findings:
Patients were classified as being allergic or non-allergic. Allergic patients had at least one positive SPT response plus
sIgE levels greater than 150 kIU/L (age > 7 years) or greater than 100 kIU/L (age 1-6 years), or a medical history of asthma,
allergic rhinoconjunctivitis, or allergic reactions to food, plus elevated sIgE levels. Fifty six percent of patients (or
parents) in the probiotic group reported improvement compared to 15% in the placebo group. During active treatment, 15% of
subjects experienced a worsening of symptoms compared with 41% in the placebo group (p = 0.04). The mean SCORAD index decreased
from 35.6 to 31.6 (p = 0.06) in the probiotic group while no changes were observed in the placebo group. For patients who
reported a subjective improvement in symptoms during treatment with the probiotic, the mean change in the total SCORAD score
was -11.4 versus a mean change for patients in the placebo group of + 6.1 (p < 0.001). There was a trend towards lower
itch scores and decreased intensity of AD in the active treatment group, but this was not statistically significant. The treatment
response was more pronounced in allergic patients compared to non-allergic patients. There was a significant decrease in the
total SCORAD score (p = 0.04) as well as a substantial decrease in the extent of the AD (p = 0.008) during active treatment
in the allergic group compared to placebo, but not in the non-allergic group. There was a significant difference in sECP levels
during active treatment compared to placebo (P = 0.03). There were no significant differences in the production of cytokines
interleukin 4, interleukin 2, interleukin 10 and interferon y between the two groups.
Practice Implications:
This trial supports earlier findings that probiotics may play a role in reducing the symptoms of AD. Two previous trials
have found that the probiotic Lactobacillus rhamnosus GG reduced severity of AD symptoms in infants with cow's milk allergy.
The results of this new trial were particularly noteworthy in children with diagnosed allergies (based on IgE scores) and
suggest a moderate effect on symptoms. Based on the results of these trials, it is interesting to suggest that probiotics
may reduce food allergies in children with AD. Future trials should focus on a greater reach of potential food allergens in
AD and the effect of long-term probiotic supplements on both AD symptoms as well as both IgE and IgG measures. Finally, it
would also be interesting to explore the impact on gut permeability in both children and adults with food allergies.
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