GastritisNCT04289519
Endoscopic Findings of Gastritis in Children
An observational study of Gastritis, run by Assiut University.
Trial summary
Gastritis defines any (histologically confirmed) inflammation of the gastric mucosa Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gastritis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 30 Apr 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 Up to 18 years
- All sexes
- Child, Adult
Study population: All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy
Who may be able to join
- All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy
Who cannot join
- • All children underwent upper endoscopy during the study period not diagnosed as gastritis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Study on Endoscopic Findings of Gastritis in Children Attending GIT Endoscopic Unit of Assiut University Children Hospital (AUCH) (15 Years)
Gastritis defines any (histologically confirmed) inflammation of the gastric mucosa
Read the detailed description
Gastritis is a very common disease in children. The main presentation of children with gastritis is recurrent abdominal pain and dyspepsia or vomiting. Young children may have hematemesis or melena as presentation. Drug induced or food related gastritis presents usually with acute symptoms but Helicobacter pylori gastritis have mainly recurrent abdominal pain and dyspeptic symptoms. Other presentations include diarrhea, constipation, flatulence, bloating, fatigue, low energy level, weight loss, muscle loss, bad breath etc.
The main causes of gastritis are infections, inflammation and other disorders affect the gastric mucosa in pediatric patients. Helicobacter pylori infection is the most common cause of gastritis in children which is also responsible for the majority of duodenal ulcers.
Acute erosive gastritis is most commonly the result of metabolic stress or drug or corrosive injury.
Other major causes of gastritis include celiac disease, allergic disorders, and Crohn's disease .Medication as NSAIDs, uremia, ischemia, shock, radiation, sepsis, trauma, severe burns and surgery.
Endoscopic pictures in acute gastritis may be in the form of:
- Multiple round-shaped severe erosions with a diameter of several millimeters.
- Mucosal edema, hyperemia.
- Peptic ulcer While in chronic gastritis is variable. Affects the antrum in the beginning and advances to the proximal in time .
- Conditions
- Gastritis
- Medical subject headings
- Gastritis
What is being measured
The primary outcome is the main question the study is designed to answer.
causes of gastritis in children as shown by upper endoscopy
- infections
- inflammation
- Helicobacter pylori
- Acute erosive gastritis
Measured: average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HM Reyad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289519
- Sponsor's protocol ID
- EFOGIC
- Status last verified
- Feb 2020
- First submitted
- 23 Sep 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pasechnikov VD, Chukov SZ, Kotelevets SM, Mostovov AN, Mernova VP, Polyakova MB. Invasive and non-invasive diagnosis of Helicobacter pylori-associated atrophic gastritis: a comparative study. Scand J Gastroenterol. 2005 Mar;40(3):297-301. doi: 10.1080/00365520410010607.
PubMed 15932170Kusters JG, van Vliet AH, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449-90. doi: 10.1128/CMR.00054-05.
PubMed 16847081Gold BD, Colletti RB, Abbott M, Czinn SJ, Elitsur Y, Hassall E, Macarthur C, Snyder J, Sherman PM; North American Society for Pediatric Gastroenterology and Nutrition. Helicobacter pylori infection in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000 Nov;31(5):490-7. doi: 10.1097/00005176-200011000-00007. No abstract available.
PubMed 11144432Tam YH, Chan KW, To KF, Cheung ST, Mou JW, Pang KK, Wong YS, Sihoe JD, Lee KH. Impact of pediatric Rome III criteria of functional dyspepsia on the diagnostic yield of upper endoscopy and predictors for a positive endoscopic finding. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):387-91. doi: 10.1097/MPG.0b013e31820e2026.
PubMed 21415670Glickman JN, Antonioli DA. Gastritis. Gastrointest Endosc Clin N Am. 2001 Oct;11(4):717-40, vii.
PubMed 11689363Kayacetin S, Guresci S. What is gastritis? What is gastropathy? How is it classified? Turk J Gastroenterol. 2014 Jun;25(3):233-47. doi: 10.5152/tjg.2014.7906.
PubMed 25141310
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on Endoscopic Findings of Gastritis in Children Attending GIT Endoscopic Unit of Assiut University Children Hospital (AUCH) (15 Years)
- ClinicalTrials.gov ID
- NCT04289519
- Acronym / sponsor ID
- EFOGIC
- Conditions
- Gastritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 28 Feb 2020 (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.
Gastritis defines any (histologically confirmed) inflammation of the gastric mucosa
Detailed description
Gastritis is a very common disease in children. The main presentation of children with gastritis is recurrent abdominal pain and dyspepsia or vomiting. Young children may have hematemesis or melena as presentation. Drug induced or food related gastritis presents usually with acute symptoms but Helicobacter pylori gastritis have mainly recurrent abdominal pain and dyspeptic symptoms. Other presentations include diarrhea, constipation, flatulence, bloating, fatigue, low energy level, weight loss, muscle loss, bad breath etc.
The main causes of gastritis are infections, inflammation and other disorders affect the gastric mucosa in pediatric patients. Helicobacter pylori infection is the most common cause of gastritis in children which is also responsible for the majority of duodenal ulcers.
Acute erosive gastritis is most commonly the result of metabolic stress or drug or corrosive injury.
Other major causes of gastritis include celiac disease, allergic disorders, and Crohn's disease .Medication as NSAIDs, uremia, ischemia, shock, radiation, sepsis, trauma, severe burns and surgery.
Endoscopic pictures in acute gastritis may be in the form of:
- Multiple round-shaped severe erosions with a diameter of several millimeters.
- Mucosal edema, hyperemia.
- Peptic ulcer While in chronic gastritis is variable. Affects the antrum in the beginning and advances to the proximal in time .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy
Key inclusion criteria (1 listed)
- All children diagnosed as gastritis by upper endoscopy and bio gastric biopsy
Key exclusion criteria (1 listed)
- • All children underwent upper endoscopy during the study period not diagnosed as gastritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
causes of gastritis in children as shown by upper endoscopy
Time frame: average 1 year
* infections * inflammation * Helicobacter pylori * Acute erosive gastritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 15932170Pasechnikov VD, Chukov SZ, Kotelevets SM, Mostovov AN, Mernova VP, Polyakova MB. Invasive and non-invasive diagnosis of Helicobacter pylori-associated atrophic gastritis: a comparative study. Scand J Gastroenterol. 2005 Mar;40(3):297-301. doi: 10.1080/00365520410010607.
- Background: PubMed 16847081Kusters JG, van Vliet AH, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449-90. doi: 10.1128/CMR.00054-05.
- Background: PubMed 11144432Gold BD, Colletti RB, Abbott M, Czinn SJ, Elitsur Y, Hassall E, Macarthur C, Snyder J, Sherman PM; North American Society for Pediatric Gastroenterology and Nutrition. Helicobacter pylori infection in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000 Nov;31(5):490-7. doi: 10.1097/00005176-200011000-00007. No abstract available.
- Background: PubMed 21415670Tam YH, Chan KW, To KF, Cheung ST, Mou JW, Pang KK, Wong YS, Sihoe JD, Lee KH. Impact of pediatric Rome III criteria of functional dyspepsia on the diagnostic yield of upper endoscopy and predictors for a positive endoscopic finding. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):387-91. doi: 10.1097/MPG.0b013e31820e2026.
- Background: PubMed 11689363Glickman JN, Antonioli DA. Gastritis. Gastrointest Endosc Clin N Am. 2001 Oct;11(4):717-40, vii.
- Background: PubMed 25141310Kayacetin S, Guresci S. What is gastritis? What is gastropathy? How is it classified? Turk J Gastroenterol. 2014 Jun;25(3):233-47. doi: 10.5152/tjg.2014.7906.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis, 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 1 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 Feb 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 Naglaa Hassan, Professor (01111872237, naglaa.ibrahim@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
causes of gastritis in children as shown by upper endoscopy (time frame: average 1 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 NCT04289519, which also lists 6 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 Feb 2020.