NCT07045857

Brief Summary

This study aims to determine recurrence rates, identify influential factors, investigate key factors that contribute to recurrence, evaluate treatment effectiveness and to assess the efficacy of different eradication regimens and their role in reducing recurrence.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

May 13, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
Last Updated

July 1, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

June 23, 2025

Last Update Submit

June 23, 2025

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • recurrence of H. Pylori infection in patients who recieved medical treatment

    H. Pylori antigen in stool

    4 weeks after successful medical treatment

Study Arms (1)

follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence

OTHER

follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence

Behavioral: follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence

Interventions

follow up of patients that had H. Pylori infection and recieved medical treatment for recurrenceBEHAVIORAL

follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence

follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-75 years old.
  • H. pylori infection: Confirmed by endoscopy, biopsy, or non-invasive tests (e.g., urea breath test, stool antigen test).
  • Symptoms: Presence of dyspepsia, peptic ulcer disease, or other H. pylori-related symptoms.
  • Laboratory tests: Normal liver and kidney function, and no significant abnormalities in blood counts.

You may not qualify if:

  • Patients receiving eradication therapy in the past taking proton pump inhibitors,, H2 blockers ,,bismuth ,, antibiotics or other medications that interfere with the result of the examination in the recent 4 weeks.
  • Gastrointestinal disorders: Severe gastrointestinal disorders (e.g., gastric cancer, inflammatory bowel disease ,gastric or duodenal ulcer with current or recent bleeding , or clinical significant gastrointestinal bleeding within 4 weeks of randomization).
  • Malignancies: Active or recent malignancies.
  • Severe comorbidities: Unstable or severe comorbidities (e.g., heart failure, liver cirrhosis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Mitchell HM, Hu P, Chi Y, Chen MH, Li YY, Hazell SL. A low rate of reinfection following effective therapy against Helicobacter pylori in a developing nation (China). Gastroenterology. 1998 Feb;114(2):256-61. doi: 10.1016/s0016-5085(98)70475-5.

    PMID: 9453484BACKGROUND

  • Chen TS, Tsay SH, Chang FY, Lee SD. Triple therapy for the eradication of Helicobacter pylori and reduction of duodenal ulcer relapse: comparison of 1 week and 2 week regimens and recrudescence rates over 12 months. J Gastroenterol Hepatol. 1995 May-Jun;10(3):300-5. doi: 10.1111/j.1440-1746.1995.tb01097.x.

    PMID: 7548807BACKGROUND

  • Anand PS, Kamath KP, Anil S. Role of dental plaque, saliva and periodontal disease in Helicobacter pylori infection. World J Gastroenterol. 2014 May 21;20(19):5639-53. doi: 10.3748/wjg.v20.i19.5639.

    PMID: 24914323BACKGROUND

Central Study Contacts

Thomas W Thabet, Resident

CONTACT

01286046059thomaswagih0@gmail.com

Usama M Abdelaal, Professor

CONTACT

01065962094

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Internal Medicine Department, Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

May 13, 2025

Primary Completion

November 20, 2025

Study Completion

November 20, 2025

Last Updated

July 1, 2025

Record last verified: 2025-05

Locations

EG(1)