Helicobacter PyloriNCT06871579
Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
A study testing EnteroTracker(R) EST in people with Helicobacter Pylori, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- EnteroTracker(R) EST
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 21 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged >=18 years
- Diagnosed with H. pylori infection (by endoscopy, stool antigen, or urea breath testing)
- Agreement to adhere to lifestyle considerations throughout study duration
- Ability of participant to provide informed consent
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
- Inability to swallow pills
- Biopsy-proven high grade dysplastic Barrett s esophagus, active peptic ulcer disease, recent (within 4 weeks) upper GI bleed, and/or history of Zollinger Ellison syndrome or gastric bypass surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
Background:
Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori.
Read more
Objective:
To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection.
Eligibility:
People aged 18 years or older with persistent H. pylori infection.
Design:
Participants will have 3 or 4 clinic visits over 2 to 4 months.
Screening visit: Participants will have a physical exam. They will provide a stool sample.
Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics.
Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again.
Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated.
...
Read the detailed description
Study Description:
Adults with active Helicobacter pylori infection will undergo an esophageal string test (EST). The gastric portion of the string will be used for detection of H. pylori by polymerase chain reaction (PCR), as well as assessment of resistance genes to clarithromycin, levofloxacin, and metronidazole. Participants will be treated per current American Gastroenterological Association (AGA) guidelines. A stool antigen test for H. pylori will be performed 4 weeks after completion of therapy to assess cure. Participants who have failed >=2 courses of therapy will undergo endoscopy with resistance testing per AGA recommendations. Patients will be offered antibiotic therapy based on the EST results and will have a repeat H. pylori stool antigen test 4 weeks after completion of therapy.
Primary Objective:
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
Secondary Objectives:
To assess the ability of the gastric portion of the EST in detecting antimicrobial resistance to clarithromycin, levofloxacin, and metronidazole.
Primary Endpoint:
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
Secondary Endpoint:
Detection of H. pylori antibiotic resistance genes in EST eluates.
- Conditions
- Helicobacter Pylori
- Being tested
- EnteroTracker(R) EST
- Keywords
- Helicobacter Pylori, Antibiotic resistance, DIAGNOSTIC TEST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnteroTracker(R) ESTDiagnostic test
The device consists of a gelatin-coated capsule with a collection string wrapped inside.
| Study group | Role | What they receive |
|---|---|---|
| EnteroTracker(R) EST | Experimental | Esophageal string test device consists of a gelatin-coated capsule with a collection string wrapped inside. Receives: Diagnostic Test: EnteroTracker(R) EST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
Measured: Baseline
Secondary outcomes (1)
Detection of H. pylori antibiotic resistance genes in EST eluates.
To assess the ability of the gastric portion of the EST in detecting antimicrobial resistance to clarithromycin, levofloxacin, and metronidazole.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start11 Jun 2025
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amy D Klion, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871579
- Sponsor's protocol ID
- 10002302
- Other IDs
- 002302-I
- Status last verified
- 1 Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li Y, Lv T, He C, Wang H, Cram DS, Zhou L, Zhang J, Jiang W. Evaluation of multiplex ARMS-PCR for detection of Helicobacter pylori mutations conferring resistance to clarithromycin and levofloxacin. Gut Pathog. 2020 Jul 10;12:35. doi: 10.1186/s13099-020-00373-6. eCollection 2020.
PubMed 32670416Han X, Yu X, Gao X, Wang X, Tay CY, Wei X, Lai B, Marshall BJ, Zhang X, Chua EG. Quantitative PCR of string-test collected gastric material: A feasible approach to detect Helicobacter pylori and its resistance against clarithromycin and levofloxacin for susceptibility-guided therapy. Helicobacter. 2023 Aug;28(4):e12985. doi: 10.1111/hel.12985. Epub 2023 Apr 17.
PubMed 37066609
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Study of the Esophageal String Test (EST) for the Diagnosis of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT06871579
- Acronym / sponsor ID
- 10002302
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter Pylori, Antibiotic resistance, DIAGNOSTIC TEST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 12 Mar 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.
Background:
Helicobacter pylori is a bacterium that infects the lining of the stomach and intestines. It can cause peptic ulcers, cancers, and infections. Current methods of diagnosing H. pylori infections have limitations. Researchers want to test a new method of testing for H. pylori.
Objective:
To compare the esophageal string test (EST) to standard tests for detecting H. pylori infection.
Eligibility:
People aged 18 years or older with persistent H. pylori infection.
Design:
Participants will have 3 or 4 clinic visits over 2 to 4 months.
Screening visit: Participants will have a physical exam. They will provide a stool sample.
Baseline visit: Participants will have blood tests. Then they will have the EST: One end of a string will be taped to the outside of their cheek; the other end will be packed into a capsule. Participants will swallow the capsule, and the string will unwind down their throat into their stomach. The string will be left in for at least 1 hour. Then researchers will gently pull out the string. The fluids soaked into the string will be studied. Some participants will be prescribed antibiotics.
Follow-up visit 1: Participants whose H. pylori infection was cured by the antibiotics may leave the study. Those who are still infected will have an endoscopy: A flexible tube will be inserted down the throat and into the stomach. It will take tissue samples from the stomach lining. These participants will then receive antibiotics again.
Follow-up visit 2: The physical exam, blood test, and stool sample will be repeated.
...
Detailed description
Study Description:
Adults with active Helicobacter pylori infection will undergo an esophageal string test (EST). The gastric portion of the string will be used for detection of H. pylori by polymerase chain reaction (PCR), as well as assessment of resistance genes to clarithromycin, levofloxacin, and metronidazole. Participants will be treated per current American Gastroenterological Association (AGA) guidelines. A stool antigen test for H. pylori will be performed 4 weeks after completion of therapy to assess cure. Participants who have failed >=2 courses of therapy will undergo endoscopy with resistance testing per AGA recommendations. Patients will be offered antibiotic therapy based on the EST results and will have a repeat H. pylori stool antigen test 4 weeks after completion of therapy.
Primary Objective:
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
Secondary Objectives:
To assess the ability of the gastric portion of the EST in detecting antimicrobial resistance to clarithromycin, levofloxacin, and metronidazole.
Primary Endpoint:
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
Secondary Endpoint:
Detection of H. pylori antibiotic resistance genes in EST eluates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnteroTracker(R) EST | Experimental | Diagnostic Test: EnteroTracker(R) ESTEsophageal string test device consists of a gelatin-coated capsule with a collection string wrapped inside. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged >=18 years
- Diagnosed with H. pylori infection (by endoscopy, stool antigen, or urea breath testing)
- Agreement to adhere to lifestyle considerations throughout study duration
- Ability of participant to provide informed consent
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Use of antibiotics with activity against H. pylori within 4 weeks of enrollment
- Inability to swallow pills
- Biopsy-proven high grade dysplastic Barrett s esophagus, active peptic ulcer disease, recent (within 4 weeks) upper GI bleed, and/or history of Zollinger Ellison syndrome or gastric bypass surgery
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 |
|---|---|---|
| EnteroTracker(R) ESTThe device consists of a gelatin-coated capsule with a collection string wrapped inside. | Diagnostic test | EnteroTracker(R) EST |
Primary outcome
Proportion of the study population identified positive for H. pylori in EST eluates by PCR.
Time frame: Baseline
To assess the sensitivity of the gastric portion of the EST in detecting H. pylori infection.
1 secondary outcome
Detection of H. pylori antibiotic resistance genes in EST eluates.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 32670416Li Y, Lv T, He C, Wang H, Cram DS, Zhou L, Zhang J, Jiang W. Evaluation of multiplex ARMS-PCR for detection of Helicobacter pylori mutations conferring resistance to clarithromycin and levofloxacin. Gut Pathog. 2020 Jul 10;12:35. doi: 10.1186/s13099-020-00373-6. eCollection 2020.
- Background: PubMed 37066609Han X, Yu X, Gao X, Wang X, Tay CY, Wei X, Lai B, Marshall BJ, Zhang X, Chua EG. Quantitative PCR of string-test collected gastric material: A feasible approach to detect Helicobacter pylori and its resistance against clarithromycin and levofloxacin for susceptibility-guided therapy. Helicobacter. 2023 Aug;28(4):e12985. doi: 10.1111/hel.12985. Epub 2023 Apr 17.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Amy D Klion, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnteroTracker(R) EST in people with Helicobacter Pylori, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the study population identified positive for H. pylori in EST eluates by PCR. (time frame: Baseline). 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 NCT06871579, which also lists 2 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 5 Oct 2026.