miRNA-155 Assay Before and After Immunotherapy and Probiotics

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.

Official Title
-----------------
MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Lacteol fort
* Drug: Standardized Timothy Grass Pollen
* Drug: Lacteol fort and Standardized Timothy Grass Pollen


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group I included 15 cases who received probiotics only. Group II included 15 children who received SLIT. Group III included 15 children who received probiotics and SLIT.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Group<br>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. | Drug: Lacteol fort<br>* Lacteol fort is a drug containing lactobacilli<br>|
| Experimental: SLIT Group<br>included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense) | Drug: Standardized Timothy Grass Pollen<br>* SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .<br>|
| Experimental: Combined treatment Group<br>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 | Drug: Lacteol fort and Standardized Timothy Grass Pollen<br>* Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total nasal symptom score between before and after treatment | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum miR-155 expression at the start and end of the study | Serum miR-155 expression was measured for the three groups by quantitative real time PCR | 6 months |