miRNA-155 Assay Before and After Immunotherapy and Probiotics

Zagazig University

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Lacteol fort and Standardized Timothy Grass Pollen; Drug: Lacteol fort; Drug: Standardized Timothy Grass Pollen

Study type: Interventional

Funder types: Other

Identifiers

NCT04603456

miR-155 in allergic rhinitis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Probiotic Group

Experimental group

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.

Treatment:

Drug: Lacteol fort

SLIT Group

Experimental group

Description:

included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)

Treatment:

Drug: Standardized Timothy Grass Pollen

Combined treatment Group

Experimental group

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

Treatment:

Drug: Lacteol fort and Standardized Timothy Grass Pollen