Back to resultsmiRNA-155 Assay Before and After Immunotherapy and Probiotics
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Lacteol fort
Standardized Timothy Grass Pollen
Lacteol fort and Standardized Timothy Grass Pollen
Sponsored by
About this trial
This is an interventional other trial for Allergic Rhinitis
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
Sites / Locations
- Zagazig university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Probiotic Group
SLIT Group
Combined treatment Group
Arm Description
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.
included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04603456
Brief Title
miRNA-155 Assay Before and After Immunotherapy and Probiotics
Official Title
MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
March 10, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic Group
Arm Type
Experimental
Arm Description
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.
Arm Title
SLIT Group
Arm Type
Experimental
Arm Description
included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)
Arm Title
Combined treatment Group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Lacteol fort
Intervention Description
Lacteol fort is a drug containing lactobacilli
Intervention Type
Drug
Intervention Name(s)
Standardized Timothy Grass Pollen
Intervention Description
SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .
Intervention Type
Drug
Intervention Name(s)
Lacteol fort and Standardized Timothy Grass Pollen
Intervention Description
Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.
Primary Outcome Measure Information:
Title
Total nasal symptom score between before and after treatment
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Serum miR-155 expression at the start and end of the study
Description
Serum miR-155 expression was measured for the three groups by quantitative real time PCR
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa Sedeek
Organizational Affiliation
Medical Microbiology and Immunology
Official's Role
Study Chair
Facility Information:
Facility Name
Zagazig university
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
11846609
Citation
Livak KJ, Schmittgen TD. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-Delta Delta C(T)) Method. Methods. 2001 Dec;25(4):402-8. doi: 10.1006/meth.2001.1262.
Results Reference
background
PubMed Identifier
18417051
Citation
Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.
Results Reference
background
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miRNA-155 Assay Before and After Immunotherapy and Probiotics
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