Gastric RefluxNCT04105894
Gastric Reflux and Sinonasal Symptoms
An observational study of Gastric Reflux and Gastro Esophageal Reflux, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Gastric Reflux, Gastro Esophageal Reflux
- What is being tested?
- MSCT of nose and PNs, Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin and medical treatment of GERD t
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Dec 2021
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant
- Significant nasal cavity malformations
- Oncological pathology
- Other sinonasal diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Gastric Reflux Induce Sinonasal Symptoms?
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
Read the 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:
- An increased coexistence of both disorders should exist compared to the general population.
- A biologically plausible pathophysological mechanism should explain how GERD can cause CRS.
- 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.
- Conditions
- Gastric Reflux, Gastro Esophageal Reflux
- Being tested
- MSCT of nose and PNs, Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin, medical treatment of GERD t
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCT of nose and PNsDevice
MSCT of nose and PNs axial, coronal and sagittal cuts without contrast to evaluate the state of the sinuses at the beginning of evaluation and after 2 months duration of medical treatment for GERD
Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsinDiagnostic test
Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin at the at the beginning of evaluation and after 2 months duration of medical treatment for GERD
medical treatment of GERD tDrug
medical treatment of GERD only for 2 months as described by gastroenterology department
What is being measured
The primary outcome is the main question the study is designed to answer.
study of correlation between sinonasal troubles & GERD
patients diagnosed with GERD who complain of sinonasal symptoms will evaluated for their response after 2 months trial of medical treatment for GERD
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study startJan 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Gastric RefluxStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abdelale Mohammed, Assiut University
- Investigators
- Mohammad Shaker, Study chair, Assiut UniversityMahmoud Ali, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105894
- Sponsor's protocol ID
- GR & sinonasal symptoms
- Status last verified
- Jan 2020
- First submitted
- 25 Sep 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
PubMed 22885331Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PubMed 16928254Vaezi MF, Katzka D, Zerbib F. Extraesophageal Symptoms and Diseases Attributed to GERD: Where is the Pendulum Swinging Now? Clin Gastroenterol Hepatol. 2018 Jul;16(7):1018-1029. doi: 10.1016/j.cgh.2018.02.001. Epub 2018 Feb 7.
PubMed 29427733Herbella FA, Patti MG. Gastroesophageal reflux disease: From pathophysiology to treatment. World J Gastroenterol. 2010 Aug 14;16(30):3745-9. doi: 10.3748/wjg.v16.i30.3745.
PubMed 20698035Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4. doi: 10.1097/00005537-200211000-00004.
PubMed 12439157O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3.
PubMed 18594333Green BT, Broughton WA, O'Connor JB. Marked improvement in nocturnal gastroesophageal reflux in a large cohort of patients with obstructive sleep apnea treated with continuous positive airway pressure. Arch Intern Med. 2003 Jan 13;163(1):41-5. doi: 10.1001/archinte.163.1.41.
PubMed 12523915Loehrl TA, Smith TL, Darling RJ, Torrico L, Prieto TE, Shaker R, Toohill RJ, Jaradeh SS. Autonomic dysfunction, vasomotor rhinitis, and extraesophageal manifestations of gastroesophageal reflux. Otolaryngol Head Neck Surg. 2002 Apr;126(4):382-7. doi: 10.1067/mhn.2002.123857.
PubMed 11997777Holma B, Lindegren M, Andersen JM. pH effects on ciliomotility and morphology of respiratory mucosa. Arch Environ Health. 1977 Sep-Oct;32(5):216-26. doi: 10.1080/00039896.1977.10667285.
PubMed 20855Lodi U, Harding SM, Coghlan HC, Guzzo MR, Walker LH. Autonomic regulation in asthmatics with gastroesophageal reflux. Chest. 1997 Jan;111(1):65-70. doi: 10.1378/chest.111.1.65.
PubMed 8995994Wong IW, Rees G, Greiff L, Myers JC, Jamieson GG, Wormald PJ. Gastroesophageal reflux disease and chronic sinusitis: in search of an esophageal-nasal reflex. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):255-9. doi: 10.2500/ajra.2010.24.3490.
PubMed 20819461Harding SM, Richter JE. The role of gastroesophageal reflux in chronic cough and asthma. Chest. 1997 May;111(5):1389-402. doi: 10.1378/chest.111.5.1389. No abstract available.
PubMed 9149599Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
PubMed 22469599Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
PubMed 12150380
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Gastric Reflux Induce Sinonasal Symptoms?
- ClinicalTrials.gov ID
- NCT04105894
- Acronym / sponsor ID
- GR & sinonasal symptoms
- Conditions
- Gastric Reflux, Gastro Esophageal Reflux
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Sep 2019 (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 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:
- An increased coexistence of both disorders should exist compared to the general population.
- A biologically plausible pathophysological mechanism should explain how GERD can cause CRS.
- 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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Pregnant
- Significant nasal cavity malformations
- Oncological pathology
- Other sinonasal diseases
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 |
|---|---|---|
| MSCT of nose and PNsMSCT of nose and PNs axial, coronal and sagittal cuts without contrast to evaluate the state of the sinuses at the beginning of evaluation and after 2 months duration of medical treatment for GERD | Device | – |
| Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsinSwab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin at the at the beginning of evaluation and after 2 months duration of medical treatment for GERD | Diagnostic test | – |
| medical treatment of GERD tmedical treatment of GERD only for 2 months as described by gastroenterology department | Drug | – |
Primary outcome
study of correlation between sinonasal troubles & GERD
Time frame: baseline
patients diagnosed with GERD who complain of sinonasal symptoms will evaluated for their response after 2 months trial of medical treatment for GERD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 22885331Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.
- Background: PubMed 16928254Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Background: PubMed 29427733Vaezi MF, Katzka D, Zerbib F. Extraesophageal Symptoms and Diseases Attributed to GERD: Where is the Pendulum Swinging Now? Clin Gastroenterol Hepatol. 2018 Jul;16(7):1018-1029. doi: 10.1016/j.cgh.2018.02.001. Epub 2018 Feb 7.
- Background: PubMed 20698035Herbella FA, Patti MG. Gastroesophageal reflux disease: From pathophysiology to treatment. World J Gastroenterol. 2010 Aug 14;16(30):3745-9. doi: 10.3748/wjg.v16.i30.3745.
- Background: PubMed 12439157Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4. doi: 10.1097/00005537-200211000-00004.
- Background: PubMed 18594333O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3.
- Background: PubMed 12523915Green BT, Broughton WA, O'Connor JB. Marked improvement in nocturnal gastroesophageal reflux in a large cohort of patients with obstructive sleep apnea treated with continuous positive airway pressure. Arch Intern Med. 2003 Jan 13;163(1):41-5. doi: 10.1001/archinte.163.1.41.
- Background: PubMed 11997777Loehrl TA, Smith TL, Darling RJ, Torrico L, Prieto TE, Shaker R, Toohill RJ, Jaradeh SS. Autonomic dysfunction, vasomotor rhinitis, and extraesophageal manifestations of gastroesophageal reflux. Otolaryngol Head Neck Surg. 2002 Apr;126(4):382-7. doi: 10.1067/mhn.2002.123857.
- Background: PubMed 20855Holma B, Lindegren M, Andersen JM. pH effects on ciliomotility and morphology of respiratory mucosa. Arch Environ Health. 1977 Sep-Oct;32(5):216-26. doi: 10.1080/00039896.1977.10667285.
- Background: PubMed 8995994Lodi U, Harding SM, Coghlan HC, Guzzo MR, Walker LH. Autonomic regulation in asthmatics with gastroesophageal reflux. Chest. 1997 Jan;111(1):65-70. doi: 10.1378/chest.111.1.65.
- Background: PubMed 20819461Wong IW, Rees G, Greiff L, Myers JC, Jamieson GG, Wormald PJ. Gastroesophageal reflux disease and chronic sinusitis: in search of an esophageal-nasal reflex. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):255-9. doi: 10.2500/ajra.2010.24.3490.
- Background: PubMed 9149599Harding SM, Richter JE. The role of gastroesophageal reflux in chronic cough and asthma. Chest. 1997 May;111(5):1389-402. doi: 10.1378/chest.111.5.1389. No abstract available.
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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.
Mohammad Shaker study chair
Assiut University
Mahmoud Ali study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Reflux and Gastro Esophageal Reflux, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rehab Abdelale (01017341596, rehab.abdel3al88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study of correlation between sinonasal troubles & GERD (time frame: baseline). 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 NCT04105894, which also lists 14 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 28 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.