Helicobacter Pylori InfectionNCT05662514
Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication
A study testing Bifidobacterium animalis subsp. lactis BLa80 in people with Helicobacter Pylori Infection and Gut Microbiota, run by Qilu Hospital of Shandong University.
Trial summary
Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Gut Microbiota
- What is being tested?
- Bifidobacterium animalis subsp. lactis BLa80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 15 Jan 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70.
- Patients with H. pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
- Patients who have did not receive H. pylori eradication treatment before.
Who cannot join
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
- Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs which might influence gut microbiota within 3 months.
- Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse.
- Patients who are unwilling or incapable to provide informed consents.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication: a Randomized Double-blind Placebo-controlled Trial
Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. In the last decade, the eradication rates of conventional regimens based on proton pump inhibitors (PPIs) plus antibiotics have been decreasing. Antibiotic resistance and decrease of drug compliance caused by adverse effects were the two main reasons for eradication failure. Moreover, H. pylori treatment causes dysbiosis of gut microbiota and increases the expression of antibiotic resistance gene. Therefore, eradication of H. pylori is facing a great challenge, and effective and safe methods are needed.
To reduce adverse effects, improve drug compliance and increase eradication rates, certain probiotics were added to conventional regimens in several clinical studies. Probiotics were more or less shown to reduce adverse effects in the vast majority of clinical studies, but whether probiotics can improve the eradication rate of H. pylori remains controversial. Meanwhile, several studies focusing on the impact of probiotics on gut microbiota during H. pylori eradication have been published recently. Thus, we conducted a randomized, double-blind, placebo-controlled trial aiming to evaluate the effects of probiotics combining with 14-day bismuth quadruple therapy on H. pylori eradication.
Read the detailed description
This was a randomized, parallel-group, double-blind and placebo-controlled study. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, patients were randomly allocated in a 1:1 ratio to receive either the investigational product or placebo along with H. pylori eradication therapy. The randomization sequence was generated using SAS 9.1.3. Eight weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. Feces samples, which were taken at the subject's home at the beginning, the end of treatment and 8 weeks after treatment completion, were collected from the patients immediately and stored at -80 °C until analysis. In this study, the influences of antibiotics and combination of probiotics on gut microbiota during H. pylori treatments were investigated using high-throughput sequencing of the 16S rRNA gene.
Patients were required to recall the history of gastrointestinal symptoms at baseline, keep the symptom diaries during the treatment and return the diaries at week 2. Gastrointestinal symptoms were assessed and scored according to the 15-iteem GSRS27 before (week 0) and after quadruple therapy (week 2). Special attention was given to the following symptoms: epigastric pain, heartburn, acid regurgatition, nausea or/and vomiting, abdominal distension, eructation, diarrhea, constipation. Adverse effects outside gastrointestine were also recorded and evaluated.
Compliance with antibiotic therapy and the investigational product was evaluated by means of a patient's diary and product accountability, while compliance with eradication therapy was evaluated through a questionnaire. After all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated.
Patients were evaluated at 4 visits: screening (10-30 days before the baseline visit), baseline, end of treatment/efficacy (14 days after the baseline visit) and follow-up (8 weeks after treatment completion). Patients were diagnosed with one (or more) of three validated methods, 13C-urea breath test, rapid urease test or histology, depending on the clinical situation of the patient. Eradication confirmation test was also performed following standard recommendations: 13C-urea breath test at 8 weeks after treatment.
- Conditions
- Helicobacter Pylori Infection, Gut Microbiota
- Being tested
- Bifidobacterium animalis subsp. lactis BLa80, Placebo
- Keywords
- Helicobacter pylori, Gut microbiota, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactis BLa80Dietary supplement
Test product contain 3 × 109 colony-forming units [CFU] Bifidobacterium animalis subsp. lactis BLa80 strains, for each packet.
Subjects ingested one packet (3 g/packet) of Test product per day (2 hours after taking antibiotics in the evening), for 14 days.
PlaceboOther
To maintain the blinding, patients in the control group received placebo included in identical packets. Control product per day (2 hours after taking antibiotics), for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Esomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, probiotic once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks. Receives: Dietary Supplement: Bifidobacterium animalis subsp. lactis BLa80 |
| Placebo group | Placebo comparator | Esomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, placebo once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota
Stool samples were collected at wk0, wk2, and wk10. Patients were instructed to collect stool samples at the medical visit site by using disposable sterile feces collection tubes. Samples were stored at -80℃ after collection immediately. In this study, the influences of antibiotics and combination of probiotics on gut microbiota during H. pylori treatments were investigated using high-throughput sequencing of the 16S rRNA gene.
Measured: Week 0, week 2 and week 10
Secondary outcomes (2)
Rate of adverse reactions
Rate of adverse reactions
Measured: Week 2 and week 10
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Feb 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhou, Dr, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662514
- Sponsor's protocol ID
- KYLL-202210-011
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang C, Liang L, Lv P, Liu L, Wang S, Wang Z, Chen Y. Effects of non-viable Lactobacillus reuteri combining with 14-day standard triple therapy on Helicobacter pylori eradication: A randomized double-blind placebo-controlled trial. Helicobacter. 2021 Dec;26(6):e12856. doi: 10.1111/hel.12856. Epub 2021 Oct 10.
PubMed 34628695Yuan Z, Xiao S, Li S, Suo B, Wang Y, Meng L, Liu Z, Yin Z, Xue Y, Zhou L. The impact of Helicobacter pylori infection, eradication therapy, and probiotics intervention on gastric microbiota in young adults. Helicobacter. 2021 Dec;26(6):e12848. doi: 10.1111/hel.12848. Epub 2021 Aug 26.
PubMed 34448282Nabavi-Rad A, Sadeghi A, Asadzadeh Aghdaei H, Yadegar A, Smith SM, Zali MR. The double-edged sword of probiotic supplementation on gut microbiota structure in Helicobacter pylori management. Gut Microbes. 2022 Jan-Dec;14(1):2108655. doi: 10.1080/19490976.2022.2108655.
PubMed 35951774Guillemard E, Poirel M, Schafer F, Quinquis L, Rossoni C, Keicher C, Wagner F, Szajewska H, Barbut F, Derrien M, Malfertheiner P. A Randomised, Controlled Trial: Effect of a Multi-Strain Fermented Milk on the Gut Microbiota Recovery after Helicobacter pylori Therapy. Nutrients. 2021 Sep 11;13(9):3171. doi: 10.3390/nu13093171.
PubMed 34579049
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Gut Microbiota During the Helicobacter Pylori Eradication: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05662514
- Acronym / sponsor ID
- KYLL-202210-011
- Conditions
- Helicobacter Pylori Infection, Gut Microbiota
- Keywords
- Helicobacter pylori, Gut microbiota, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 22 Dec 2022 (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.
Helicobacter pylori (H. pylori) is still infecting more than half of the population in many countries, although the prevalence is decreasing. As a main cause of chronic gastritis, peptic ulcer, and malignant gastric tumors, H. pylori places a heavy burden on developing countries and regions with high infection rate. In the last decade, the eradication rates of conventional regimens based on proton pump inhibitors (PPIs) plus antibiotics have been decreasing. Antibiotic resistance and decrease of drug compliance caused by adverse effects were the two main reasons for eradication failure. Moreover, H. pylori treatment causes dysbiosis of gut microbiota and increases the expression of antibiotic resistance gene. Therefore, eradication of H. pylori is facing a great challenge, and effective and safe methods are needed.
To reduce adverse effects, improve drug compliance and increase eradication rates, certain probiotics were added to conventional regimens in several clinical studies. Probiotics were more or less shown to reduce adverse effects in the vast majority of clinical studies, but whether probiotics can improve the eradication rate of H. pylori remains controversial. Meanwhile, several studies focusing on the impact of probiotics on gut microbiota during H. pylori eradication have been published recently. Thus, we conducted a randomized, double-blind, placebo-controlled trial aiming to evaluate the effects of probiotics combining with 14-day bismuth quadruple therapy on H. pylori eradication.
Detailed description
This was a randomized, parallel-group, double-blind and placebo-controlled study. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, patients were randomly allocated in a 1:1 ratio to receive either the investigational product or placebo along with H. pylori eradication therapy. The randomization sequence was generated using SAS 9.1.3. Eight weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results. Feces samples, which were taken at the subject's home at the beginning, the end of treatment and 8 weeks after treatment completion, were collected from the patients immediately and stored at -80 °C until analysis. In this study, the influences of antibiotics and combination of probiotics on gut microbiota during H. pylori treatments were investigated using high-throughput sequencing of the 16S rRNA gene.
Patients were required to recall the history of gastrointestinal symptoms at baseline, keep the symptom diaries during the treatment and return the diaries at week 2. Gastrointestinal symptoms were assessed and scored according to the 15-iteem GSRS27 before (week 0) and after quadruple therapy (week 2). Special attention was given to the following symptoms: epigastric pain, heartburn, acid regurgatition, nausea or/and vomiting, abdominal distension, eructation, diarrhea, constipation. Adverse effects outside gastrointestine were also recorded and evaluated.
Compliance with antibiotic therapy and the investigational product was evaluated by means of a patient's diary and product accountability, while compliance with eradication therapy was evaluated through a questionnaire. After all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated.
Patients were evaluated at 4 visits: screening (10-30 days before the baseline visit), baseline, end of treatment/efficacy (14 days after the baseline visit) and follow-up (8 weeks after treatment completion). Patients were diagnosed with one (or more) of three validated methods, 13C-urea breath test, rapid urease test or histology, depending on the clinical situation of the patient. Eradication confirmation test was also performed following standard recommendations: 13C-urea breath test at 8 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Bifidobacterium animalis subsp. lactis BLa80Esomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, probiotic once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks. |
| Placebo group | Placebo comparator | Other: PlaceboEsomeprazole 20 mg and bismuth 2g twice daily before meals, amoxicillin 1 g, and clarithromycin 500 mg twice daily after meals, placebo once a day with one packet each time 2 hours after taking medicine above in the evening, for 2 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70.
- Patients with H. pylori infection (Positive for rapid urease test or 13C/14C-urea breath test).
- Patients who have did not receive H. pylori eradication treatment before.
Key exclusion criteria (8 listed)
- Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
- Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
- Patients with active gastrointestinal bleeding.
- Patients with a history of upper gastrointestinal surgery.
- Patients allergic to treatment drugs.
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactis BLa80Test product contain 3 × 109 colony-forming units [CFU] Bifidobacterium animalis subsp. lactis BLa80 strains, for each packet. Subjects ingested one packet (3 g/packet) of Test product per day (2 hours after taking antibiotics in the evening), for 14 days. | Dietary supplement | Probiotic group |
| PlaceboTo maintain the blinding, patients in the control group received placebo included in identical packets. Control product per day (2 hours after taking antibiotics), for 14 days. | Other | Placebo group |
Primary outcome
Gut microbiota
Time frame: Week 0, week 2 and week 10
Stool samples were collected at wk0, wk2, and wk10. Patients were instructed to collect stool samples at the medical visit site by using disposable sterile feces collection tubes. Samples were stored at -80℃ after collection immediately. In this study, the influences of antibiotics and combination of probiotics on gut microbiota during H. pylori treatments were investigated using high-throughput sequencing of the 16S rRNA gene.
2 secondary outcomes
Rate of adverse reactions
Time frame: Week 2 and week 10
Patient compliance
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 34628695Yang C, Liang L, Lv P, Liu L, Wang S, Wang Z, Chen Y. Effects of non-viable Lactobacillus reuteri combining with 14-day standard triple therapy on Helicobacter pylori eradication: A randomized double-blind placebo-controlled trial. Helicobacter. 2021 Dec;26(6):e12856. doi: 10.1111/hel.12856. Epub 2021 Oct 10.
- Background: PubMed 34448282Yuan Z, Xiao S, Li S, Suo B, Wang Y, Meng L, Liu Z, Yin Z, Xue Y, Zhou L. The impact of Helicobacter pylori infection, eradication therapy, and probiotics intervention on gastric microbiota in young adults. Helicobacter. 2021 Dec;26(6):e12848. doi: 10.1111/hel.12848. Epub 2021 Aug 26.
- Background: PubMed 35951774Nabavi-Rad A, Sadeghi A, Asadzadeh Aghdaei H, Yadegar A, Smith SM, Zali MR. The double-edged sword of probiotic supplementation on gut microbiota structure in Helicobacter pylori management. Gut Microbes. 2022 Jan-Dec;14(1):2108655. doi: 10.1080/19490976.2022.2108655.
- Results publication: PubMed 34579049Guillemard E, Poirel M, Schafer F, Quinquis L, Rossoni C, Keicher C, Wagner F, Szajewska H, Barbut F, Derrien M, Malfertheiner P. A Randomised, Controlled Trial: Effect of a Multi-Strain Fermented Milk on the Gut Microbiota Recovery after Helicobacter pylori Therapy. Nutrients. 2021 Sep 11;13(9):3171. doi: 10.3390/nu13093171.
- Individual participant dataSharing planned: No
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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.
Tao Zhou, Dr study chair
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium animalis subsp. lactis BLa80 in people with Helicobacter Pylori Infection and Gut Microbiota, run by Qilu Hospital of Shandong University.
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 8 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhou, Dr (18560086097, lyynqj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: Week 0, week 2 and week 10). 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 NCT05662514, which also lists 4 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 9 Feb 2023.