Allergic Asthma Clinical Trial
Official title:
Efficacy of Lactbacillus GG on Wheeze and Allergic Sensitization in Infants at Risk
Given that asthma results from a complex interaction between genetic susceptibility and environmental factors and rates of childhood asthma are increasing, primary prevention has to focus on modifiable aspects such as nutrition. There a implications from epidemiology that food supplementation with probiotics given to atopic mothers in pregnancy and during lactation can prevent the development allergies in the offspring. Children with atopic dermatitis are at increased risk (up to 80%) of developing persistent respiratory tract disease. Our trial examined whether probiotics are able to prevent allergic sensitization and allergic asthma when given to 6-24 month old infants at an increased risk of allergies.
In our investigator-initiated prospective study, a total of 170 children with at least two
episodes of wheezing and a first degree family history of atopic disease were recruited from
our walk-in clinic between October 2002 and October 2004. We chose this relatively long
period of time to exclude a seasonal selection bias (e.g., upper airway infections or
airborne allergens). 131 eligible children (6 to 24 month old) were randomly assigned to a
double-blind dietary supplementation with Lactobacillus rhamnosus strain GG ATCC 53103 (LGG)
twice daily or placebo over six months. A computerized randomization schedule was prepared
by a biostatistician with allocation and dispensing of capsules by the distributor of LGG.
The capsules were matched for size, shape, and volume of content, which was reconstituted
with 5 ml water and then given by spoon. Compliance was monitored by use of a capsule chart
(completed by parents) and capsule counts. The parents were asked to keep a diary provided
by the study group. Clinical monitoring was done for one year: before the intervention
(visit 1), after 3, 6, 9, and 12 months (visit 2 to 5). It encompassed episodes of asthmatic
exacerbations defined as cough and wheeze, numbers and days of associated hospitalizations,
symptom free days, days without use of rescue medication (steroid suppositoria, a frequently
used device in Western Europe), and associated inhalative steroid and beta-agonist use.
Children underwent a physical examination including determination of the severity scoring of
atopic dermatitis (SCORAD) index to assess eczema severity examination on each study visit
to our walk-in clinic. To ensure consistency, the same investigator performed all SCORAD
assessments. Atopic eczema was confirmed by characteristical cutaneous findings, pruritus,
and chronic relapsing course. This last criterion was fulfilled if the child presented
eczema for at least one month on at least one visit. Asthma diagnosis was based on an
algorithm from an international paediatric asthma consensus group. Asthma was diagnosed if
the child had chronic or recurrent cough, wheeze or shortness of breath, or both, and if
other diagnosis were excluded and trial antiasthmatic treatment was effective. Blood samples
were taken on visit 1, 3, and 5. Sensitization to common dietary and respiratory allergen
was measured by total and antigen specific IgE assays against hen’s egg, cat epithelia,
house dust mite (D1+2), birch pollen, milk protein, lactalbumin, timothy pollen, horse
epithelia and alternaria by chemiluminescence-immunoassay. This highly-sensitive assay is
suitable especially for the determination of low value of specific IgE. Additionally,
eosinophilic cationic protein and eosinophils were determined.
Primary outcome measures were the asthma-related clinical events. Secondary measures were
the serum concentrations of IgE, specific IgE, ECP, Eos, IL-2 soluble receptor alpha
(IL-2Rα, to reflect T-cell related inflammatory state) and transforming growth factor beta
(TGFβ, a profibrotic factor whose expression is increased in asthmatics, indicating airway
remodeling. All parents supplied written informed consent prior to the study. Human
experimentation guidelines of Good Clinical Practice, the German Drug Act and the
declaration of Helsinki / Hong Kong were followed in the conduct of clinical research.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03850626 -
Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
|
||
Completed |
NCT02911688 -
Effect of Gamma Tocopherol Enriched Supplementation on Response to Inhaled O3 Exposure
|
Phase 2 | |
Active, not recruiting |
NCT01776177 -
The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy
|
N/A | |
Completed |
NCT00485576 -
Safety and Efficacy Study of Eculizumab in Patients With Mild Allergic Asthma
|
Phase 2 | |
Completed |
NCT00515775 -
Influence of a Inhaled Corticosteroid Therapy Versus Corticosteroid + LABA Therapy on the FeNO of Asthmatic Children
|
N/A | |
Completed |
NCT00736801 -
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma
|
N/A | |
Completed |
NCT04259164 -
Anti-inflammatory Effects Glycopyrronium
|
Phase 3 | |
Active, not recruiting |
NCT04619017 -
Airway Immune Response to Allergens (Use Lay Language Here)
|
Phase 1 | |
Completed |
NCT01699594 -
Change in Airway Responsiveness After Allergen Exposure
|
N/A | |
Completed |
NCT01353755 -
2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma
|
Phase 3 | |
Completed |
NCT00999466 -
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
|
Phase 2 | |
Completed |
NCT00434434 -
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
|
Phase 2 | |
Completed |
NCT00492076 -
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma
|
Phase 4 | |
Completed |
NCT00829179 -
Role of RhuMab-E25 in Reducing Exhaled Nitric Oxide (NO) in Allergic Asthma
|
Phase 3 | |
Recruiting |
NCT04542902 -
Non-coding RNAs Analysis of Eosinophil Subtypes in Asthma
|
N/A | |
Recruiting |
NCT04109534 -
Effect of a Dietary Fatty Acid Supplementation on Symptoms and Bronchial Inflammation in Patients With Asthma
|
N/A | |
Active, not recruiting |
NCT05186025 -
Tyrosine Allergoid Paediatric and Adult Study
|
||
Withdrawn |
NCT03307278 -
House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance
|
N/A | |
Enrolling by invitation |
NCT06151938 -
Evaluate Measurement Instruments Relevance in Assessing Effectiveness of ACARIZAX® in House Dust Mite Allergic Rhinitis
|
||
Withdrawn |
NCT04401631 -
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation
|