miRNA-155 Assay Before and After Immunotherapy and Probiotics

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Lacteol fort; Drug: Lacteol fort and Standardized Timothy Grass Pollen; Drug: Standardized Timothy Grass Pollen

• Registration Number: NCT04603456
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-03-10
• Study Completion: 2019-05-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-11
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic Group	Lacteol fort	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.
Combined treatment Group	Lacteol fort and Standardized Timothy Grass Pollen	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
SLIT Group	Standardized Timothy Grass Pollen	included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)

Primary Outcome Measures

Name	Time	Method
Total nasal symptom score between before and after treatment	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 Outcome Measures

Name	Time	Method
Serum miR-155 expression at the start and end of the study	6 months	Serum miR-155 expression was measured for the three groups by quantitative real time PCR

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Sharkia, Egypt