Helicobacter Pylori InfectionPhase 2NCT05483660
A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
A Phase 2 study testing Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans in people with Helicobacter Pylori Infection, run by Nanfang Hospital, Southern Medical University.
Trial summary
The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Aug 2024
- Phase
- Phase 2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75 years.
- Diagnosed by 13C-UBT within 2 weeks before entry.
Who cannot join
- Previous treatment for H. pylori infection.
- Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
- Previous history of gastrointestinal surgery.
- Severe or unstable diseases.
- Pregnancy or lactation.
- Alcoholics and drug abusers.
- Staff of this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.
Read the detailed description
All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10^10 per time, three times daily) or Bacillus coagulans (1.5×10^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lactobacillus plantarum, Bacillus coagulans, Lactobacillus plantarum + Bacillus coagulans, Placebo
- Keywords
- Gastric Probiotics, Side-effect, Eradication rate, Helicobacter pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarumOther
1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Bacillus coagulansOther
1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Lactobacillus plantarum + Bacillus coagulansOther
1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
PlaceboOther
Adult milk powder 15 g pertime, three times daily and half an hour before meal.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus plantarum | Experimental | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. Receives: Other: Lactobacillus plantarum |
| Bacillus coagulans | Experimental | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. Receives: Other: Bacillus coagulans |
| Lactobacillus plantarum + Bacillus coagulans | Experimental | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. Receives: Other: Lactobacillus plantarum + Bacillus coagulans |
| Placebo | Placebo comparator | Adult milk powder 15 g per time, three times daily and half an hour before meal. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Helicobacter pylori
All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.
Measured: The eighth week of the trial
Secondary outcomes (5)
The condition of gastrointestinal symptoms before the trial
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the baseline level of their gastrointestinal symptoms before they receive the probiotic or placebo.
Measured: Baseline
The condition of gastrointestinal symptoms in the first week
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo already a week.
Measured: The first week of the trial.
The condition of gastrointestinal symptoms in the second week
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after two weeks.
Measured: The second week of the trial.
The condition of gastrointestinal symptoms in the third week
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after three weeks.
Measured: The third week of the trial.
The condition of gastrointestinal symptoms in the fourth week
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms at the fourth week of this trial.
Measured: The fourth week of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483660
- Sponsor's protocol ID
- NFEC-2022-252
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT05483660
- Acronym / sponsor ID
- NFEC-2022-252
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Gastric Probiotics, Side-effect, Eradication rate, Helicobacter pylori
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Aug 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.
The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.
Detailed description
All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10^10 per time, three times daily) or Bacillus coagulans (1.5×10^10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus plantarum | Experimental | Other: Lactobacillus plantarum1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
| Bacillus coagulans | Experimental | Other: Bacillus coagulans1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
| Lactobacillus plantarum + Bacillus coagulans | Experimental | Other: Lactobacillus plantarum + Bacillus coagulans1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
| Placebo | Placebo comparator | Other: PlaceboAdult milk powder 15 g per time, three times daily and half an hour before meal. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-75 years.
- Diagnosed by 13C-UBT within 2 weeks before entry.
Key exclusion criteria (7 listed)
- Previous treatment for H. pylori infection.
- Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
- Previous history of gastrointestinal surgery.
- Severe or unstable diseases.
- Pregnancy or lactation.
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 |
|---|---|---|
| Lactobacillus plantarum1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other | Lactobacillus plantarum |
| Bacillus coagulans1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other | Bacillus coagulans |
| Lactobacillus plantarum + Bacillus coagulans1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. | Other | Lactobacillus plantarum + Bacillus coagulans |
| PlaceboAdult milk powder 15 g pertime, three times daily and half an hour before meal. | Other | Placebo |
Primary outcome
Eradication of Helicobacter pylori
Time frame: The eighth week of the trial
All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.
5 secondary outcomes
The condition of gastrointestinal symptoms before the trial
Time frame: Baseline
The condition of gastrointestinal symptoms in the first week
Time frame: The first week of the trial.
The condition of gastrointestinal symptoms in the second week
Time frame: The second week of the trial.
The condition of gastrointestinal symptoms in the third week
Time frame: The third week of the trial.
The condition of gastrointestinal symptoms in the fourth week
Time frame: The fourth week of the trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans in people with Helicobacter Pylori Infection, run by Nanfang Hospital, Southern Medical 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 2 inclusion and 7 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 2 Aug 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yang Bai (13925001665, 13925001665@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Helicobacter pylori (time frame: The eighth week of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022.