A Phase 4 interventional study of Lacteol fort and Standardized Timothy Grass Pollen in Allergic Rhinitis, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by Zagazig University · Phase 4, Interventional, and Other
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 45 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)
Drug: 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
Drug: Lacteol fort and Standardized Timothy Grass Pollen
Lacteol fort is a drug containing lactobacilli
SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .
Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.
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
Time frame: 6 months
Serum miR-155 expression at the start and end of the study
Serum miR-155 expression was measured for the three groups by quantitative real time PCR
Time frame: 6 months
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Zagazig University