MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Total nasal symptom score between before and after treatment
Study Overview
Brief Summary
The investigators aimed to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.
Detailed Description
Allergic rhinitis (AR) is an inflammatory state characterized by a disturbance of immunoregulatory mechanisms that leads to an amplified T helper "Th-2" response. Micro-RNAs (miRNAs) are short single-stranded RNA molecules that post transcriptionally control gene expression and can mediate allergic process. The aim of this study was to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 5-18 years
- •Diagnosed as having AR
- •With positive skin test to grass pollen
Exclusion Criteria
- •Anatomical abnormalities of upper respiratory tract,
- •Previous immunotherapy,
- •Clinically significant inflammatory diseases,
- •Malignancies,
- •Chronic treatment with systemic corticosteroids or immune suppressive drugs
Arms & Interventions
Probiotic Group
consisted of 15 cases who received probiotics only. A drug called Lacteol fort (Rameda Company) . A sachet was taken once daily for three months. Each sachet contains 10 billions lactobacilli.
Intervention: Lacteol fort (Drug)
SLIT Group
included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)
Intervention: Standardized Timothy Grass Pollen (Drug)
Combined treatment Group
included 15 children who received probiotics and SLIT. A drug called Lacteol fort was administered A sachet was taken once daily for 3 months . Standardized Timothy Grass Pollen was taken for 6 months
Intervention: Lacteol fort and Standardized Timothy Grass Pollen (Drug)
Outcomes
Primary Outcomes
Total nasal symptom score between before and after treatment
Time Frame: 6 months
Total Nasal Symptom Score was evaluated for the three groups at the start of the study and after 6 months. TNSS is the sum of scores for each of nasal obstruction, sneezing, nasal itching, and rhinorrhea at each time point, by means of a four-point scale (0-3) . TNSS is estimated by addition of the score for each of the symptoms to a total out of 12
Secondary Outcomes
- Serum miR-155 expression at the start and end of the study(6 months)
Investigators
Fedaa Nabil
Assisstant lecturer
Zagazig University