miRNA-155 Assay Before and After Immunotherapy and Probiotics

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603456
• Other study ID #: miR-155 in allergic rhinitis
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: October 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 1, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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 in?ammatory diseases,
• Malignancies,
• Chronic treatment with systemic corticosteroids or immune suppressive drugs

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Lacteol fort
Lacteol fort is a drug containing lactobacilli
• Standardized Timothy Grass Pollen
SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .
• Lacteol fort and Standardized Timothy Grass Pollen
Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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