miRNA-155 Assay Before and After Immunotherapy and Probiotics

NCT04603456 | Completed Phase 4

• 1 other identifier: miR-155 in allergic rhinitis
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (3)

Probiotic Group

EXPERIMENTAL

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.

Drug: Lacteol fort

SLIT Group

EXPERIMENTAL

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

Drug: Standardized Timothy Grass Pollen

Combined treatment Group

EXPERIMENTAL

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

Drug: Lacteol fort and Standardized Timothy Grass Pollen

Interventions

Lacteol fort DRUG

Lacteol fort is a drug containing lactobacilli

Probiotic Group

Standardized Timothy Grass Pollen DRUG

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

SLIT Group

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.

Combined treatment Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 5-18 years
• Diagnosed as having AR
• With positive skin test to grass pollen

You may not qualify if:

• Anatomical abnormalities of upper respiratory tract,
• Previous immunotherapy,
• Clinically significant inflammatory diseases,
• Malignancies,
• Chronic treatment with systemic corticosteroids or immune suppressive drugs

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Publications (2)

• 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. doi: 10.1006/meth.2001.1262.

  PMID: 11846609 BACKGROUND

• Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.

  PMID: 18417051 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Randa Sedeek

  Medical Microbiology and Immunology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 26, 2020
• Study Start: September 1, 2018
• Primary Completion: March 10, 2019
• Study Completion: May 1, 2019
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

EG (1)