NCT04105894

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

September 25, 2019

Last Update Submit

January 27, 2020

Conditions

Gastric RefluxGastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Interventions

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 22885331BACKGROUND

  • Vakil 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.

    PMID: 16928254BACKGROUND

  • Vaezi 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.

    PMID: 29427733BACKGROUND

  • Herbella 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.

    PMID: 20698035BACKGROUND

  • Tasker 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.

    PMID: 12439157BACKGROUND

  • O'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.

    PMID: 18594333BACKGROUND

  • Green 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.

    PMID: 12523915BACKGROUND

  • Loehrl 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.

    PMID: 11997777BACKGROUND

  • Holma 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.

    PMID: 20855BACKGROUND

  • Lodi 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.

    PMID: 8995994BACKGROUND

  • Wong 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.

    PMID: 20819461BACKGROUND

  • Harding 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.

    PMID: 9149599BACKGROUND

  • Fokkens 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.

    PMID: 22469599BACKGROUND

  • Belafsky 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.

    PMID: 12150380BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Mohammad Shaker

    Assiut University

    STUDY CHAIR

  • Mahmoud Ali

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Rehab Abdelale

CONTACT

01017341596rehab.abdel3al88@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Otorhinolaryngology Department

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

January 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

January 28, 2020

Record last verified: 2020-01