NCT05830357

Brief Summary

Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation. aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

April 14, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

Helicobacter pyloridyspepsiachildrenyoung adultsprevalencepeptic ulcerrisk factors

Outcome Measures

Primary Outcomes (1)

  • Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate

    determine the prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate by examining stool samples from 667 patients to detect h.pylori antigen

    12 weeks following the startpoint of the study.

Secondary Outcomes (1)

  • detecting risk factors related to Helicobacter Pylori infection in children and young adults in sohag governorate

    12 weeks following the startpoint of the study

Eligibility Criteria

Age2 Years - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Study population will be chosen by random sampling technique among children and young adults (between 2 to 25 years old) attending internal medicine and pediatric out- patient clinics at Sohag University hospital.

You may qualify if:

  • children and young adults (between 2 to 25 years old)

You may not qualify if:

  • children below 2 years old
  • adults more than 25 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine-Sohag university

Sohag, 093, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool specimen

MeSH Terms

Conditions

DyspepsiaPeptic Ulcer

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator at family medicine department

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

May 1, 2023

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations