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NCT Number: NCT04603456

miRNA-155 Assay Before and After Immunotherapy and Probiotics

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacteol fort

Drug

Lacteol fort is a drug containing lactobacilli

Standardized Timothy Grass Pollen

Drug

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

Lacteol fort and Standardized Timothy Grass Pollen

Drug

Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.

Primary outcomes

  1. 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

  1. Serum miR-155 expression at the start and end of the study

    Time frame: 6 months

    Serum miR-155 expression was measured for the three groups by quantitative real time PCR

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2020
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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