- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802732
Stool Antigen In Diagnosis Of Helicobacter Pylori
Diagnostic Accuracy Of Stool Antigen In Diagnosis Of Helicobacter Pylori Infection In Children
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Khalid I Abd El-Rahman, Professor
- Phone Number: 01005484357
- Email: Khaled.elsaih@med.au.edu.eg
Study Contact Backup
- Name: Ashraf M Elsaghier, PhD
- Phone Number: 01026746762
- Email: Ashraf.elsaghier@med.au.edu.eg
Study Locations
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Assiut, Egypt
- Recruiting
- Assiut University Hospital
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Contact:
- Khalid I Abd El-Rahman, Professor
- Phone Number: 01005484357
- Email: Khaled.elsaih@med.au.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Children and adolescents between 4 and 18 years old having chronic or reccurent unexplained dyspeptic symptoms (epigastric pain, post prandial fullness, early satiety, bleching, heart burn, bloating, flatulence, regurgitation, nausea, vomiting and/ or halitosis)(Miwa et al.,2012) and/ or non variceal hematemesis
2. The dyspeptic symptoms should be present at least 2months duration , which doesn't need to be consecutive, during the previous 6 months.(Rasquin et al., 2006)
Exclusion Criteria:
- 1. Patients who received anti sectertory drugs and/ or antibiotics in the previous 4 weeks before endoscopy.
2. Patients less than 4years and more than 18 years old.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents
Time Frame: over one year
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Patients presented with chronic or recurrent unexplained dyspeptic symptoms and/or non variceal hematemesis will be submitted for stool antigen test
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over one year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.
- Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
- Moubri M, Kalach N, Larras R, Berrah H, Mouffok F, Guechi Z, Cadranel S. Adapted first-line treatment of Helicobacter pylori infection in Algerian children. Ann Gastroenterol. 2019 Jan-Feb;32(1):60-66. doi: 10.20524/aog.2018.0317. Epub 2018 Oct 3.
- Kato S, Shimizu T, Toyoda S, Gold BD, Ida S, Ishige T, Fujimura S, Kamiya S, Konno M, Kuwabara K, Ushijima K, Yoshimura N, Nakayama Y; Japanese Society for Pediatric Gastroenterology, Hepatology and Nutrition. The updated JSPGHAN guidelines for the management of Helicobacter pylori infection in childhood. Pediatr Int. 2020 Dec;62(12):1315-1331. doi: 10.1111/ped.14388.
- Galicia Poblet G, Alarcon Cavero T, Alonso Perez N, Borrell Martinez B, Botija Arcos G, Cilleruelo Pascual ML, Gonzalez Martin LM, Hernandez Hernandez A, Martinez Escribano B, Ortola Castells X, Rizo Pascual J, Urruzuno Telleria P, Vegas Alvarez AM. Management of Helicobacter pylori infection in the pediatric age. An Pediatr (Engl Ed). 2021 Nov;95(5):383.e1-383.e9. doi: 10.1016/j.anpede.2021.05.004. Epub 2021 Oct 9.
- Huh CW, Kim BW. [Diagnosis of Helicobacter pylori Infection]. Korean J Gastroenterol. 2018 Nov 25;72(5):229-236. doi: 10.4166/kjg.2018.72.5.229. Korean.
- Breckan RK, Paulssen EJ, Asfeldt AM, Kvamme JM, Straume B, Florholmen J. The All-Age Prevalence of Helicobacter pylori Infection and Potential Transmission Routes. A Population-Based Study. Helicobacter. 2016 Dec;21(6):586-595. doi: 10.1111/hel.12316. Epub 2016 May 12.
- Qualia CM, Katzman PJ, Brown MR, Kooros K. A report of two children with Helicobacter heilmannii gastritis and review of the literature. Pediatr Dev Pathol. 2007 Sep-Oct;10(5):391-4. doi: 10.2350/06-09-0159.1.
- Miwa H, Ghoshal UC, Gonlachanvit S, Gwee KA, Ang TL, Chang FY, Fock KM, Hongo M, Hou X, Kachintorn U, Ke M, Lai KH, Lee KJ, Lu CL, Mahadeva S, Miura S, Park H, Rhee PL, Sugano K, Vilaichone RK, Wong BC, Bak YT. Asian consensus report on functional dyspepsia. J Neurogastroenterol Motil. 2012 Apr;18(2):150-68. doi: 10.5056/jnm.2012.18.2.150. Epub 2012 Apr 9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAOSADOHPIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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