Gastric Reflux and Sinonasal Symptoms

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04105894
Collaborator
(none)
40
23

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: MSCT of nose and PNs
  • Diagnostic Test: Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin
  • Drug: medical treatment of GERD t

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Does Gastric Reflux Induce Sinonasal Symptoms?
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. study of correlation between sinonasal troubles & GERD [baseline]

    patients diagnosed with GERD who complain of sinonasal symptoms will evaluated for their response after 2 months trial of medical treatment for GERD

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Mohammad Shaker, Assiut University
  • Study Director: Mahmoud Ali, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rehab Abdelale Mohammed, Resident in Otorhinolaryngology Department, Assiut University
ClinicalTrials.gov Identifier:
NCT04105894
Other Study ID Numbers:
  • GR & sinonasal symptoms
First Posted:
Sep 26, 2019
Last Update Posted:
Jan 28, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2020