Stool Antigen In Diagnosis Of Helicobacter Pylori

NCT05802732 | Unknown

• 1 other identifier: DAOSADOHPIC
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori is among the most common bacterial infections in humans. Helicobacter pylori is a Gram-negative, S -shaped rod .The most likely mode of transmission is fecal-oral or oral-oral. Helicobacter pylori infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. The majority of children with Helicobacter pylori infection remain asymptomatic, although a percentage of the infected children do develop Helicobacter. pylori-associated diseases. Helicobacter pylori is closely associated with the development of gastritis, gastric or duodenal ulcers. Helicobacter pylori infection can manifest with abdominal pain or vomiting and, less often, refractory iron deficiency anemia or growth retardation. Helicobacter pylori can be associated, though rarely, with chronic autoimmune thrombocytopenia. Anemia, idiopathic thrombocytopenic purpura, short stature, and sudden infant death syndrome (SIDS) have also been reported as possible extra-gastric manifestations of Helicobacter pylori infection . The diagnosis of Helicobacter pylori infection is made histologically by demonstrating the organism in the biopsy specimens. 13 C-urea breath tests and stool antigen tests are reliable noninvasive methods of detecting Helicobacter pylori infection in patients who do not require endoscopic evaluation. However, some guidelines recommend that non-invasive assessment methods are reserved to determine whether Helicobacter pylori has been eradicated not for diagnosis .However Helicobacter pylori-associated gastritis may, however, be an incidental histopathologic finding during upper endoscopy performed for unrelated indications such as the diagnosis of inflammatory bowel disease, or celiac disease.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents

  Patients presented with chronic or recurrent unexplained dyspeptic symptoms and/or non variceal hematemesis will be submitted for stool antigen test

  over one year

Interventions

Stool Antigen test DIAGNOSTIC_TEST

Correlation between the result of endoscopic biopsy and stool antigen test

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will include children and adolescents recruited from the Gastroenterology, Hepatology And Endoscopy Unit at Assuit University, Children's Hospital.

You may qualify if:

• \- 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
• \. 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)

You may not qualify if:

• \- 1. Patients who received anti sectertory drugs and/ or antibiotics in the previous 4 weeks before endoscopy.
• \. Patients less than 4years and more than 18 years old.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 30598593 BACKGROUND

• 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.

  PMID: 32657507 BACKGROUND

• 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.

  PMID: 34642127 BACKGROUND

• 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.

  PMID: 28541262 BACKGROUND

• 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.

  PMID: 30642138 BACKGROUND

• 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.

  PMID: 27172105 BACKGROUND

• 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.

  PMID: 17929990 BACKGROUND

• 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.

  PMID: 16678566 BACKGROUND

• 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.

  PMID: 22523724 BACKGROUND

Central Study Contacts

Khalid I Abd El-Rahman, Professor

CONTACT

01005484357; Khaled.elsaih@med.au.edu.eg

Ashraf M Elsaghier, PhD

CONTACT

01026746762; Ashraf.elsaghier@med.au.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 6, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)