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Helicobacter Pylori InfectionNCT05802732

Stool Antigen In Diagnosis Of Helicobacter Pylori

An observational study of Helicobacter Pylori Infection, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Stool Antigen test
How many people
63 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to Apr 2024
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 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

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

Egypt1 site, 1 recruiting

  • Assiut University Hospital

    Asyut

    Khalid I Abd El-Rahman, Professor, 01005484357, Khaled.elsaih@med.au.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Diagnostic Accuracy Of Stool Antigen In Diagnosis Of Helicobacter Pylori Infection In Children

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.

Being tested
Stool Antigen test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stool Antigen testDiagnostic test

    Correlation between the result of endoscopic biopsy and stool antigen test

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: over one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start1 Jan 2023
  3. Primary completionJan 2024 (estimated)
  4. Study completionApr 2024 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05802732
Sponsor's protocol ID
DAOSADOHPIC
Status last verified
Mar 2023
First submitted
25 Mar 2023
Last updated
6 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30598593

  • 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.

    PubMed 32657507

  • 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.

    PubMed 34642127

  • 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.

    PubMed 28541262

  • 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.

    PubMed 30642138

  • 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.

    PubMed 27172105

  • 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.

    PubMed 17929990

  • 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.

    PubMed 16678566

  • 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.

    PubMed 22523724

Questions about this trial

What is this clinical trial studying?

An observational study of Helicobacter Pylori Infection, run by Assiut University at 1 site in Egypt.

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 2 inclusion and 2 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Khalid I Abd El-Rahman, Professor (01005484357, Khaled.elsaih@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents (time frame: over one year). 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 NCT05802732, which also lists 9 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 6 Apr 2023.

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