Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05951998
Other study ID # H.pylori infection in children
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04550858 - h.Pylori Ttt With Rebamipide
Completed NCT03650543 - Effect of the CYP2C19 Polymorphism in Helicobacter Pylori Eradication Phase 4
Recruiting NCT04022109 - Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Completed NCT05857163 - Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection Phase 3
Not yet recruiting NCT06176547 - Relation of Helicobacter Pylori in Prediabetic Patients
Not yet recruiting NCT06425393 - Intrafamilial Helicobacter Pylori Infection in Hong Kong N/A
Not yet recruiting NCT05882968 - Prevalence of H.Pylori in CKD Patients
Completed NCT03837210 - Comparative Anti Helicobacter Pylori Efficacy Assessment of Unani Formulation and Quintuple Regimen Phase 2/Phase 3
Completed NCT02332213 - Volatile Markers in Digestive Cancer
Completed NCT03592069 - Concomitant Versus Hybrid Regimen for H. Pylori Eradication Phase 4
Completed NCT06315478 - Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians Phase 4
Recruiting NCT06431737 - Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication