Clinical trial NCT04105894: Gastric Reflux and Sinonasal Symptoms
Official title: Does Gastric Reflux Induce Sinonasal Symptoms?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Reflux
Gastro Esophageal Reflux
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged from18-50 years who have been diagnosed to have gastric reflux by gastroenterology departement before the start of treatment, and they also have sinonasal symptoms.

Brief summary: The study is conducted to:

* study correlation between sinonasal troubles \& GERD
* Assess whether antireflux therapy improve state of sinus in patients complaining from reflux \& sinonasal symptoms

Detailed description: Gatroesophageal reflux disease(GERD) is one of the most common diagnoses made by both primary care physicians and gastroenterologists . It is defined as a gastrointestinal motility disorder that results from the reflux of stomach contents into the esophagus or oral cavity, causing symptoms or complications .The prevalence of GERD is estimated to be between 20 and 30% of adults in western countries.

Some studies have found a correlation between GERD and certain diseases of the airway and a proposed association to others. Both asthma and laryngitis can be caused by GERD. Pepsin has been discovered in the middle ear of children with middle ear effusion and GERD has been implicated in the pathophysiology of otitis media with effusion. The authors conclude that there may be a role of antireflux therapy in patients with otitis media with effusion. The relationship between reflux and snoring/obstructive sleep apnea syndrome (OSAS) has been studied, and it is known that OSAS patients have a high incidence of nocturnal gatroesophageal reflux (nGER).

The coexistence of reflux and various respiratory disorders can be used to argue that there is probably a correlation between reflux and CRS. Though some data indicate an association between GERD and upper airway inflammatory disease, this remains a matter of controversy in today's medicine. It is suggested that, if an upper or lower respiratory tract disorder is causally related to GERD, certain criteria should be met:

1. An increased coexistence of both disorders should exist compared to the general population.
2. A biologically plausible pathophysological mechanism should explain how GERD can cause CRS.
3. clinical manifestations of the suspected GERD-related CRS should respond to anti-reflux therapy.

There are Some theories for the relation between gastric reflux and CRS. The first one is the direct exposure of the nasal and nasopharyngeal mucosa to gastric acid causing inflammation of the mucosa and impaired mucociliary clearance which could cause obstruction of sinus ostia and recurrent infections. It is known that pH variations affect ciliary motility and morphology in the respiratory mucosa.The second hypothesis is a relationship mediated by the vagus nerve; a mechanism already proven in the lower airway and in the nasal mucosa of patients with rhinitis but not in patients with CRS.

Dysfunction of the autonomic nervous system can lead to reflex sinonasal swelling and inflammation, and consequent blockage of the ostia. Demonstrated that by infusing saline with hydrochloric acid in the lower esophagus of healthy volunteers, there was increased production of nasal mucus, increased score of nasal symptoms, and reduced peak nasal inspiratory flow.

Eligibility criteria: Inclusion Criteria:

* Patient aged from18-50 years who have been diagnosed to have gastric reflux by gastroenterology departement before the start of treatment, and they also have sinonasal symptoms.

Exclusion Criteria:

* Pregnant
* Significant nasal cavity malformations
* Oncological pathology
* Other sinonasal diseases

Primary outcomes:
measure: study of correlation between sinonasal troubles & GERD
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohammad Shaker
role: STUDY_CHAIR
affiliation: Assiut University
name: Mahmoud Ali
role: STUDY_DIRECTOR
References:
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