Helicobacter Pylori InfectionPhase 4NCT07704255
Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection
A Phase 4 study testing transanal fecal bacteria transplant in people with Helicobacter Pylori Infection, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- transanal fecal bacteria transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 31 Dec 2026
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ages 18-70
- 2. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
- 3. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.
Who cannot join
- 1. Antibiotics and bismuth were taken within 4 weeks before this treatment; Or had taken PPI, H2 receptor antagonist, P-CAB within 2 weeks prior to treatment;
- 2. Pregnant or lactating women;
- 3. Those who are allergic to the investigational drugs used in this test or have contraindications;
- 4. Participated in other drug trials within 3 months before the treatment of this trial;
- 5. There are other serious diseases that affect the evaluation of this study at the same time, or they cannot correctly express their own complaints and cannot cooperate;
- 6. Subjects with dysphagia;
Show all 9Show fewer
- 7. Patients with malignant tumors, serious concomitant diseases, severe ulcer bleeding or perforation;
- 8. Patients judged by the investigator to be unsuitable for clinical trials.
- 9. Those who do not want to sign the informed consent for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 601172
Caiping Gao, Doctor, 17708130286, gaocaip@126.com
About this study
To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- transanal fecal bacteria transplant
- Keywords
- washed microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transanal fecal bacteria transplantBiological
Received transanal fecal bacteria transplant
| Study group | Role | What they receive |
|---|---|---|
| washed microbiota | Experimental | Study on the effect of washed microbiota transplantation on eradication of refractory Helicobacter pylori infection. Receives: Biological: transanal fecal bacteria transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether Hp is successfully eradicated
The successful eradication of Hp was determined by 13C urea breath test, immunohistochemical staining of Hp and Hp culture.test, immunohistochemical staining of gastric mucosa and Hp culture
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao Caiping, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704255
- Sponsor's protocol ID
- 20240507
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen YC, Malfertheiner P, Yu HT, Kuo CL, Chang YY, Meng FT, Wu YX, Hsiao JL, Chen MJ, Lin KP, Wu CY, Lin JT, O'Morain C, Megraud F, Lee WC, El-Omar EM, Wu MS, Liou JM. Global Prevalence of Helicobacter pylori Infection and Incidence of Gastric Cancer Between 1980 and 2022. Gastroenterology. 2024 Apr;166(4):605-619. doi: 10.1053/j.gastro.2023.12.022. Epub 2024 Jan 2.
PubMed 38176660Kuo CJ, Lee CH, Chang ML, Lin CY, Lin WR, Su MY, Chiu CH, Tseng CN, Wu YS, Chiu CT, Lai CH. Multidrug resistance: The clinical dilemma of refractory Helicobacter pylori infection. J Microbiol Immunol Infect. 2021 Dec;54(6):1184-1187. doi: 10.1016/j.jmii.2021.03.006. Epub 2021 Mar 23.
PubMed 33840604Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423.
PubMed 29562147Su NY, Shi Q, Mei H, Hu J, Liu YX, Liu HN, Liu HQ, Guo Y, Wang XW, Lan CH. Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis. Helicobacter. 2023 Oct;28(5):e13003. doi: 10.1111/hel.13003. Epub 2023 Aug 10.
PubMed 37565458Shirai N, Sugimoto M, Kodaira C, Nishino M, Ikuma M, Kajimura M, Ohashi K, Ishizaki T, Hishida A, Furuta T. Dual therapy with high doses of rabeprazole and amoxicillin versus triple therapy with rabeprazole, amoxicillin, and metronidazole as a rescue regimen for Helicobacter pylori infection after the standard triple therapy. Eur J Clin Pharmacol. 2007 Aug;63(8):743-9. doi: 10.1007/s00228-007-0302-8. Epub 2007 Jun 13.
PubMed 17565490Liu D, Wang J, Xie Y. Refractory Helicobacter pylori infection and the gastric microbiota. Front Cell Infect Microbiol. 2022 Sep 27;12:976710. doi: 10.3389/fcimb.2022.976710. eCollection 2022.
PubMed 36237432Shirzad-Aski H, Besharat S, Kienesberger S, Sohrabi A, Roshandel G, Amiriani T, Norouzi A, Keshtkar A. Association Between Helicobacter pylori Colonization and Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2021 May-Jun 01;55(5):380-392. doi: 10.1097/MCG.0000000000001415.
PubMed 32833699Tepler A, Narula N, Peek RM Jr, Patel A, Edelson C, Colombel JF, Shah SC. Systematic review with meta-analysis: association between Helicobacter pylori CagA seropositivity and odds of inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(2):121-131. doi: 10.1111/apt.15306. Epub 2019 Jun 5.
PubMed 31165513Ismail HF, Fick P, Zhang J, Lynch RG, Berg DJ. Depletion of neutrophils in IL-10(-/-) mice delays clearance of gastric Helicobacter infection and decreases the Th1 immune response to Helicobacter. J Immunol. 2003 Apr 1;170(7):3782-9. doi: 10.4049/jimmunol.170.7.3782.
PubMed 12646644Ismail HF, Zhang J, Lynch RG, Wang Y, Berg DJ. Role for complement in development of Helicobacter-induced gastritis in interleukin-10-deficient mice. Infect Immun. 2003 Dec;71(12):7140-8. doi: 10.1128/IAI.71.12.7140-7148.2003.
PubMed 14638805Chen W, Shu D, Chadwick VS. Helicobacter pylori infection: mechanism of colonization and functional dyspepsia Reduced colonization of gastric mucosa by Helicobacter pylori in mice deficient in interleukin-10. J Gastroenterol Hepatol. 2001 Apr;16(4):377-83. doi: 10.1046/j.1440-1746.2001.02459.x.
PubMed 11354274Ye ZN, Xia HH, Zhang R, Li L, Wu LH, Liu XJ, Xie WR, He XX. The Efficacy of Washed Microbiota Transplantation on Helicobacter pylori Eradication: A Pilot Study. Gastroenterol Res Pract. 2020 Oct 19;2020:8825189. doi: 10.1155/2020/8825189. eCollection 2020.
PubMed 33133183Brunse A, Martin L, Rasmussen TS, Christensen L, Skovsted Cilieborg M, Wiese M, Khakimov B, Pieper R, Nielsen DS, Sangild PT, Thymann T. Effect of fecal microbiota transplantation route of administration on gut colonization and host response in preterm pigs. ISME J. 2019 Mar;13(3):720-733. doi: 10.1038/s41396-018-0301-z. Epub 2018 Oct 26.
PubMed 30367124de Klerk N, Maudsdotter L, Gebreegziabher H, Saroj SD, Eriksson B, Eriksson OS, Roos S, Linden S, Sjolinder H, Jonsson AB. Lactobacilli Reduce Helicobacter pylori Attachment to Host Gastric Epithelial Cells by Inhibiting Adhesion Gene Expression. Infect Immun. 2016 Apr 22;84(5):1526-1535. doi: 10.1128/IAI.00163-16. Print 2016 May.
PubMed 26930708Guarner F, Malagelada JR. Gut flora in health and disease. Lancet. 2003 Feb 8;361(9356):512-9. doi: 10.1016/S0140-6736(03)12489-0.
PubMed 12583961
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07704255
- Acronym / sponsor ID
- 20240507
- Conditions
- Helicobacter Pylori Infection
- Keywords
- washed microbiota
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jul 2026 (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.
To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| washed microbiota | Experimental | Biological: transanal fecal bacteria transplantStudy on the effect of washed microbiota transplantation on eradication of refractory Helicobacter pylori infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Ages 18-70
- 2. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
- 3. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.
Key exclusion criteria (9 listed)
- 1. Antibiotics and bismuth were taken within 4 weeks before this treatment; Or had taken PPI, H2 receptor antagonist, P-CAB within 2 weeks prior to treatment;
- 2. Pregnant or lactating women;
- 3. Those who are allergic to the investigational drugs used in this test or have contraindications;
- 4. Participated in other drug trials within 3 months before the treatment of this trial;
- 5. There are other serious diseases that affect the evaluation of this study at the same time, or they cannot correctly express their own complaints and cannot cooperate;
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 |
|---|---|---|
| transanal fecal bacteria transplantReceived transanal fecal bacteria transplant | Biological | washed microbiota |
Primary outcome
Whether Hp is successfully eradicated
Time frame: 2years
The successful eradication of Hp was determined by 13C urea breath test, immunohistochemical staining of Hp and Hp culture.test, immunohistochemical staining of gastric mucosa and Hp culture
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 15 Jul 2026.
- Background: PubMed 38176660Chen YC, Malfertheiner P, Yu HT, Kuo CL, Chang YY, Meng FT, Wu YX, Hsiao JL, Chen MJ, Lin KP, Wu CY, Lin JT, O'Morain C, Megraud F, Lee WC, El-Omar EM, Wu MS, Liou JM. Global Prevalence of Helicobacter pylori Infection and Incidence of Gastric Cancer Between 1980 and 2022. Gastroenterology. 2024 Apr;166(4):605-619. doi: 10.1053/j.gastro.2023.12.022. Epub 2024 Jan 2.
- Background: PubMed 33840604Kuo CJ, Lee CH, Chang ML, Lin CY, Lin WR, Su MY, Chiu CH, Tseng CN, Wu YS, Chiu CT, Lai CH. Multidrug resistance: The clinical dilemma of refractory Helicobacter pylori infection. J Microbiol Immunol Infect. 2021 Dec;54(6):1184-1187. doi: 10.1016/j.jmii.2021.03.006. Epub 2021 Mar 23.
- Background: PubMed 29562147Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423.
- Background: PubMed 37565458Su NY, Shi Q, Mei H, Hu J, Liu YX, Liu HN, Liu HQ, Guo Y, Wang XW, Lan CH. Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis. Helicobacter. 2023 Oct;28(5):e13003. doi: 10.1111/hel.13003. Epub 2023 Aug 10.
- Background: PubMed 17565490Shirai N, Sugimoto M, Kodaira C, Nishino M, Ikuma M, Kajimura M, Ohashi K, Ishizaki T, Hishida A, Furuta T. Dual therapy with high doses of rabeprazole and amoxicillin versus triple therapy with rabeprazole, amoxicillin, and metronidazole as a rescue regimen for Helicobacter pylori infection after the standard triple therapy. Eur J Clin Pharmacol. 2007 Aug;63(8):743-9. doi: 10.1007/s00228-007-0302-8. Epub 2007 Jun 13.
- Background: PubMed 36237432Liu D, Wang J, Xie Y. Refractory Helicobacter pylori infection and the gastric microbiota. Front Cell Infect Microbiol. 2022 Sep 27;12:976710. doi: 10.3389/fcimb.2022.976710. eCollection 2022.
- Background: PubMed 32833699Shirzad-Aski H, Besharat S, Kienesberger S, Sohrabi A, Roshandel G, Amiriani T, Norouzi A, Keshtkar A. Association Between Helicobacter pylori Colonization and Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2021 May-Jun 01;55(5):380-392. doi: 10.1097/MCG.0000000000001415.
- Background: PubMed 31165513Tepler A, Narula N, Peek RM Jr, Patel A, Edelson C, Colombel JF, Shah SC. Systematic review with meta-analysis: association between Helicobacter pylori CagA seropositivity and odds of inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(2):121-131. doi: 10.1111/apt.15306. Epub 2019 Jun 5.
- Background: PubMed 12646644Ismail HF, Fick P, Zhang J, Lynch RG, Berg DJ. Depletion of neutrophils in IL-10(-/-) mice delays clearance of gastric Helicobacter infection and decreases the Th1 immune response to Helicobacter. J Immunol. 2003 Apr 1;170(7):3782-9. doi: 10.4049/jimmunol.170.7.3782.
- Background: PubMed 14638805Ismail HF, Zhang J, Lynch RG, Wang Y, Berg DJ. Role for complement in development of Helicobacter-induced gastritis in interleukin-10-deficient mice. Infect Immun. 2003 Dec;71(12):7140-8. doi: 10.1128/IAI.71.12.7140-7148.2003.
- Background: PubMed 11354274Chen W, Shu D, Chadwick VS. Helicobacter pylori infection: mechanism of colonization and functional dyspepsia Reduced colonization of gastric mucosa by Helicobacter pylori in mice deficient in interleukin-10. J Gastroenterol Hepatol. 2001 Apr;16(4):377-83. doi: 10.1046/j.1440-1746.2001.02459.x.
- Background: PubMed 33133183Ye ZN, Xia HH, Zhang R, Li L, Wu LH, Liu XJ, Xie WR, He XX. The Efficacy of Washed Microbiota Transplantation on Helicobacter pylori Eradication: A Pilot Study. Gastroenterol Res Pract. 2020 Oct 19;2020:8825189. doi: 10.1155/2020/8825189. eCollection 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transanal fecal bacteria transplant in people with Helicobacter Pylori Infection, run by Sichuan Provincial People's Hospital at 1 site in China.
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 3 inclusion and 9 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 15 Jul 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Gao Caiping, Doctor (17708130286, gaocaip@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether Hp is successfully eradicated (time frame: 2years). 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 NCT07704255, which also lists 18 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 15 Jul 2026.