CClinicalTrials.gg
RecruitingNCT05907733Updated Jun 18, 2023

Brain-derived Neurotrophic Factor (BDNF) Single Nucleotide Gene Polymorphism and Nerve Growth Factor as Risk Factors That Increase Severity of Allergic Rhinitis

An observational study in Allergic Rhinitis, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Allergic diseases such as asthma, allergic rhinitis (AR) and atopic dermatitis affect more than 25% of the world population and are the leading cause of illness in children. The complex interplay between genetic, environmental and immunological risk factors results in the manifestation of allergic diseases . The pathological presentation of allergic disease involves the activation of both the innate and adaptive immune systems, resulting in a multifaceted response in specific target tissues such as the airways . This response results in the recruitment of inflammatory cells to target tissues and the production of specific IgE antibodies, cytokines and other inflammatory mediators [11], [12]. It is well established that allergic inflammation triggers neuronal dysfunction, which activates specific inflammatory mechanisms, potentially leading to structural changes in the diseased tissue . Neurotrophins are a family of structurally related proteins initially discovered to be involved in regulating neuronal development and now known to govern both peripheral and central nerve growth.

BDNF is a secretory protein belonging to the neurotrophin family and is involved in a range of neural processes during human development [19], [20]. In the early stages of development BDNF is essential for neurogenesis, survival and maturation of neuronal pathways. In the adult, alongside neurotransmitters, hormones and other neurotrophins, BDNF maintains synaptic plasticity, dendritic growth and the consolidation of long-term memory. The biological effect of BDNF is mediated via its binding to the trkB receptor. The activation of these receptors on eosinophils may be important in regulating the inflammatory cascade leading to allergic disease [15], [24]. Neurotrophin mediated activation of bronchial eosinophils might therefore play a role in the regulation of eosinophilic inflammation in allergic asthma .

The BDNF gene is located on chromosome 11p13 and is alternatively spliced resulting in several different transcripts [26]. Genetic polymorphisms in BDNF have been associated with allergic phenotypes such atopic dermatitis [27] and asthma [28], [29], [30], [31] in different populations. The functional polymorphism rs6265 (Val66Met) has been shown to regulate intracellular trafficking and affect the secretion of BDNF [32]. Nerve growth factor (NGF), a neurotrophin that is expressed in the glandular, nasal epithelium, and peripheral nerves in the nasal mucosa, has been shown to induce biochemical and structural changes in nerves that can lead to hyper-responsiveness [33], [34], [35] The biological effects of neurotrophins are mediated by binding either to the high-affinity tyrosine kinase (trk) receptors or to the low-affinity receptors known as pan-neurotrophin receptor p-75.

02

Conditions studied

  • Allergic Rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's planned enrollment of 50 is below the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

This study will be conducted on 50 patients 30 patients diagnosed as a clinical disease of AR according to the diagnostic criteria of AR based on, its Impact on Asthma criteria, the patient's history of allergic symptoms, and allergy test results using the ImmunoCAP system.

Inclusion criteria

  • The chronic AR patients on anti-allergic .

Exclusion criteria

Exclusion Criteria:

  • The chronic AR patients on anti-allergic therapy will be excluded.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testGenotyping.

    5 ml biood withdrawen by venipuncture in EDTA tube DNA extraction will be done after centrifucation and used for quantatitive Real-time polymerase chain reaction.

    Also known as: Measurement of Nerve growth factor serum level

06

What researchers measure

Primary outcomes

  1. BDNF gene single nucleotide polymorphism with Allergic rhinitis risk

    will measure in blood

    Time frame: 2 months

  2. Nerve growth factor serum level

    will measure in blood for the risk of Allergic rhinitis.

    Time frame: 2 months

  3. IL-1 serum level

    will measure in blood for the risk of Allergic rhinitis.

    Time frame: 2 months

  4. C-reactive protein serum level

    will measure in blood for the risk of Allergic rhinitis.

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Sohag university Hospital
    Sohag, Egypt
    • Magdy M Amin, professor · Contact
    Recruiting
08

References and documents

Publications

  • Nathan RA. The burden of allergic rhinitis. Allergy Asthma Proc. 2007 Jan-Feb;28(1):3-9. doi: 10.2500/aap.2007.28.2934. PubMed 17390749 ↗
  • Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available. PubMed 18331513 ↗
  • Devereux G. The increase in the prevalence of asthma and allergy: food for thought. Nat Rev Immunol. 2006 Nov;6(11):869-74. doi: 10.1038/nri1958. PubMed 17063187 ↗
  • Vercelli D. Discovering susceptibility genes for asthma and allergy. Nat Rev Immunol. 2008 Mar;8(3):169-82. doi: 10.1038/nri2257. PubMed 18301422 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05907733
Lead sponsor
Sohag University
Responsible party
Zainab Mahmoud Kadry (lecturer of medical biochemistry, Sohag University) — Principal investigator
First posted
Jun 18, 2023
Start date
Jun 1, 2023
Primary completion
Aug 10, 2023 (estimated)
Completion
Aug 10, 2023 (estimated)
Last update
Jun 18, 2023

Study contacts

zeinab M Kadry, lecturer
Contact
zainbmahmoud@med.sohag.edu.eg
01225960747

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion