Frequency of h.Pylori in Children With Dyspeptic Symptoms

H.Pylori Infection Clinical Trial

Official title:

Frequency and Risk Factors of H.Pylori Infection in Children Presented by Dyspeptic Symptoms in Assiut University Children Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05951998
• Other study ID #: H.pylori infection in children
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Mariam S Fayek
• Phone: 01277773806
• Email: romasmsmfayek[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current work aim to:

Estimation of prevalence, Estimation of risk factors, Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.

Description:

Helicobacter pylori infection is a common problem in pediatric practice, it's an important cause of gastrointestinal pathology in children and its acquisition is related with poor socioeconomic conditions. H.pylori is a spiral, microaerophilic, gram-negative bacterium with four to six unipolar sheathed flagella.The human stomach, especially the antrum, is the most common reservoir of this agent. American board of orthodontists antibody blood group and Lewis blood-group antigen might expose cases to H. pylori infection, the most likely mode of transmission is fecal-oral or oral-oral. H.pylori infection is predominantly acquired during early childhood .

The majority of children with are asymptomatic although a percentage of the infected children develop H. pylori associated diseases such as iron deficiency anemia, B12 deficiency, chronic thrombocytopenic purpura. It can manifest with burning pain in the stomach, nausea, loss of appetite, bloating, weight loss.

Previous studies showed that geographic area, age, race, educational level, sanitation, and socioeconomic status are among the factors that influence the prevalence of H. pylori infection . No gender differences were found in the prevalence of H. pylori infection, while it was much higher among white people.

The overall prevalence of H. pylori infection in Egyptian school children was 72.38%. There was no significant difference in the prevalence of infection between boys and girls (73.80% vs. 70.34% respectively, or in the independent effect of sex by age. Of school children living in Sohag, 96.7% tested positive for H. pylori, compared with 81.3% of children from Giza and 61.9% from Cairo. Prevalence was also highest among children of low socio-economic class and decreased gradually among children of medium to high socio-economic class.

In a previous study conducted by Hunt et al., the prevalence of H. pylori was reported to be 48% among 2-4-year-old children in Ethiopia, while in Nigeria and Mexico it was 82% and 43%, respectively, among 5-9-year-old children..

The endoscopic findings in order of decreasing frequency in the Pediatric group were nodularity (93.0%), mucosal swelling (32.6%), spotty redness (25.6%), diffuse redness (18.6%), atrophy (9.3%), enlarged fold (4.7%), depressive erosion (4.7%), foveolar-hyperplastic polyp (2.3%), patchy redness (2.3%), red streak (2.3%), and raised erosion (2.3%).

Invasive and non-invasive tests could be used for diagnosis, while the gold standard is a biopsy specimen of gastrointestinal tract.

Triple therapy is considered to be the standard treatment for children. Proton pump inhibitor combined with two antibiotics has been shown to be very effective in clearing H. pylori from the stomach, it is recommended to treat with amoxicillin, clarithromycin and a proton pump inhibitor for 2 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children from age of 3 years to age of 18 years.

• Children presented with chronic or recurrent dyspeptic symptoms(epigastric pain, post prandial fullness, early satiety, bleaching, heart burn ,bloating ,flatulence ,regurgitation ,nausea ,vomiting and/or halitosis) and/or non variceal hematemesis.

Exclusion Criteria:

• Children less than 3 years and more than 18 years.

• Children with variceal hematemesis.

Related Conditions & MeSH terms

• H.Pylori Infection
• Helicobacter Infections
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of frequency of H.pylori infection	2.Estimation of prevalence of H.pylori infection; 3.Estimation of risk factors of H.pylori infection; 4.Estimation of endoscopic picture of H. pylori infection in children presented with chronic or recurrent dyspeptic symptoms and/or non variceal hematemesis.	Baseline