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miRNA-155 Assay Before and After Immunotherapy and Probiotics

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04603456
Enrollment
45
Registered
2020-10-26
Start date
2018-09-01
Completion date
2019-05-01
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

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.

Interventions

DRUGLacteol fort

Lacteol fort is a drug containing lactobacilli

DRUGStandardized Timothy Grass Pollen

SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .

DRUGLacteol 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Total nasal symptom score between before and after treatment6 monthsTotal 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

MeasureTime frameDescription
Serum miR-155 expression at the start and end of the study6 monthsSerum miR-155 expression was measured for the three groups by quantitative real time PCR

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026