Allergic RhinitisPhase 4NCT04603456
miRNA-155 Assay Before and After Immunotherapy and Probiotics
A Phase 4 study testing Lacteol fort, Standardized Timothy Grass Pollen and Lacteol fort and Standardized Timothy Grass Pollen in people with Allergic Rhinitis, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Lacteol fort, Standardized Timothy Grass Pollen and Lacteol fort and Standardized Timothy Grass Pollen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 5-18 years
- Diagnosed as having AR
- With positive skin test to grass pollen
Who cannot join
- Anatomical abnormalities of upper respiratory tract,
- Previous immunotherapy,
- Clinically significant inflammatory diseases,
- Malignancies,
- Chronic treatment with systemic corticosteroids or immune suppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual 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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Lacteol fort, Standardized Timothy Grass Pollen, Lacteol fort and Standardized Timothy Grass Pollen
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacteol fortDrug
Lacteol fort is a drug containing lactobacilli
Standardized Timothy Grass PollenDrug
SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .
Lacteol fort and Standardized Timothy Grass PollenDrug
Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lacteol fort |
| SLIT Group | Experimental | included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense) Receives: 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 Receives: Drug: Lacteol fort and Standardized Timothy Grass Pollen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Sep 2018
- Primary completion10 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fedaa Nabil, Zagazig University
- Investigators
- Randa Sedeek, Study chair, Medical Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603456
- Sponsor's protocol ID
- miR-155 in allergic rhinitis
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11846609Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.
PubMed 18417051
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics
- ClinicalTrials.gov ID
- NCT04603456
- Acronym / sponsor ID
- miR-155 in allergic rhinitis
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Drug: Lacteol fortconsisted 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. |
| SLIT Group | Experimental | Drug: Standardized Timothy Grass Pollenincluded 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense) |
| Combined treatment Group | Experimental | Drug: Lacteol fort and Standardized Timothy Grass Pollenincluded 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 |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children aged 5-18 years
- Diagnosed as having AR
- With positive skin test to grass pollen
Key exclusion criteria (5 listed)
- Anatomical abnormalities of upper respiratory tract,
- Previous immunotherapy,
- Clinically significant inflammatory diseases,
- Malignancies,
- Chronic treatment with systemic corticosteroids or immune suppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacteol fortLacteol fort is a drug containing lactobacilli | Drug | Probiotic Group |
| Standardized Timothy Grass PollenSLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) . | Drug | SLIT Group |
| Lacteol fort and Standardized Timothy Grass PollenLacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases. | Drug | Combined treatment Group |
Primary outcome
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
1 secondary outcome
Serum miR-155 expression at the start and end of the study
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Background: PubMed 11846609Livak 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.
- Background: PubMed 18417051Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randa Sedeek study chair
Medical Microbiology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacteol fort, Standardized Timothy Grass Pollen and Lacteol fort and Standardized Timothy Grass Pollen in people with Allergic Rhinitis, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total nasal symptom score between before and after treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.