H. Pylori InfectionNCT07045857
Recurrence of H Pylori : Incidence and Influential Factors.
A study testing follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence in people with H. Pylori Infection, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 13 May 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Usama M Abdelaal, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor, 01090801900
About this study
Official title: Recurrence of H Pylori : Incidence and Influential Factors in Sohag Government.
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.
- Conditions
- H. Pylori Infection
- Being tested
- follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow up of patients that had H. Pylori infection and recieved medical treatment for recurrenceBehavioural
follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of H. Pylori infection in patients who recieved medical treatment
- Pylori antigen in stool
Measured: 4 weeks after successful medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start13 May 2025
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Wagih Thabet, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045857
- Sponsor's protocol ID
- Soh-Med--25-5-11MS
- Status last verified
- May 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9453484Chen 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.
PubMed 7548807Anand 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.
PubMed 24914323
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence of H Pylori : Incidence and Influential Factors in Sohag Government.
- ClinicalTrials.gov ID
- NCT07045857
- Acronym / sponsor ID
- Soh-Med--25-5-11MS
- Conditions
- H. Pylori Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence | Other | Behavioral: follow up of patients that had H. Pylori infection and recieved medical treatment for recurrencefollow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow up of patients that had H. Pylori infection and recieved medical treatment for recurrencefollow up of patients that had H. Pylori infection and recieved medical treatment for recurrence and influential factors for recurrence | Behavioural | follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence |
Primary outcome
recurrence of H. Pylori infection in patients who recieved medical treatment
Time frame: 4 weeks after successful medical treatment
H. Pylori antigen in stool
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Background: PubMed 9453484Mitchell 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.
- Background: PubMed 7548807Chen 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.
- Background: PubMed 24914323Anand 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.
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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.
Usama M Abdelaal, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follow up of patients that had H. Pylori infection and recieved medical treatment for recurrence in people with H. Pylori Infection, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas W Thabet, Resident (01286046059, thomaswagih0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of H. Pylori infection in patients who recieved medical treatment (time frame: 4 weeks after successful medical treatment). 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 NCT07045857, which also lists 3 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 1 Jul 2025.