EfficacyNCT03377933
The Effects Probiotic Has on Gastromicroecology and Combined With Quadruple Regimen for H Pylori Infection
A study testing Compound Lactobacillus acidophilus in people with Efficacy and Gastric Microbiota, run by Yiqi Du at 1 site in China.
Trial summary
This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Efficacy, Gastric Microbiota, Safety
- What is being tested?
- Compound Lactobacillus acidophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2019to 15 Mar 2020
- 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
- All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures.
Who cannot join
- Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection
This study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.
Read the detailed description
Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, <10% show H. pylori related dyspepsia, 15%~20% develop into peptic ulcer, <1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases.
With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians.
Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate.
Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.
- Conditions
- Efficacy, Gastric Microbiota, Safety
- Being tested
- Compound Lactobacillus acidophilus
- Keywords
- Helicobacter pylori, Probiotics, Efficacy, Safety, gastromicroecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Lactobacillus acidophilusOther
Also called Yi Jun Kang
Compound Lactobacillus acidophilus Tablet
| Study group | Role | What they receive |
|---|---|---|
| probiotics and quadruple therapy | Experimental | Patients are given two-week compound Lactobacillus acidophilus probiotic (1 g t.i.d.), followed by a quadruple antibiotic regimen (esomeprazole [20 mg b.i.d.] + bismuth potassium citrate [220 mg b.i.d.] + tetracycline [750 mg b.i.d.] + furazolidone [100 mg b.i.d.]) for 10 days as rescue therapy.Meanwhile perform endoscopy and take gastric mucosa specimens for gene sequencing before and after the application of probiotic. Receives: Other: Compound Lactobacillus acidophilus |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene-level changes in the gastric microbiota
study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
Measured: 2 weeks
Secondary outcomes (2)
eradication rate of the therapy
using the 13C-urea breath test at 4 weeks after the end of therapy
Measured: 4 weeks
the incidence of the adverse effects
record the side effects on the 2 week, 4 week.
Measured: 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start15 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion15 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center exploratory study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yiqi Du
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yiqi Du, Changhai Hospital
- Investigators
- Yi Qi Du, professor, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377933
- Sponsor's protocol ID
- chbs230023-1
- Status last verified
- Jun 2019
- First submitted
- 1 Dec 2017
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: study protocal
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Compound Lactobacillus Acidophilus Has on Gastromicroecology and Combined With Tetracycline- and Furazolidone- Containing Quadruple Regimen as Rescue Treatment for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT03377933
- Acronym / sponsor ID
- chbs230023-1
- Conditions
- Efficacy, Gastric Microbiota, Safety
- Keywords
- Helicobacter pylori, Probiotics, Efficacy, Safety, gastromicroecology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yiqi DuUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 15 Mar 2020 (estimated)
- First posted
- 19 Dec 2017 (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 assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for H. pylori infection. Eradication was evaluated using the 13C-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. Besides study gene-level changes in the gastric microbiota following use of probiotics.
Detailed description
Currently the infection rate of H. pylori is high. H. pylori infection has a close relationship with human diseases , Among the patients with H. pylori infection, 100% have active gastritis, <10% show H. pylori related dyspepsia, 15%~20% develop into peptic ulcer, <1% ultimately evolve into gastric malignant tumor. H. pylori gastritis has been defined as an infective disease. Eradication of H. pylori plays an important role in the cure, reversal and delay of these diseases.
With the widespread eradication of H. pylori, antibiotics resistance rates are increasing seriously. The resistance of antibiotics results in the increase of H. pylori eradication failure rate. Choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians.
Besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit H. pylori to increase the eradication rate.
Investigators previously retrospectively analyzed 30 patients with H. pylori eradication failures at least two times given two-week compound Lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the ITT eradication rate was 92.1%, and 94.6% PP analysis. Side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center exploratory study
| Arm | Type | Receives |
|---|---|---|
| probiotics and quadruple therapy | Experimental | Other: Compound Lactobacillus acidophilusPatients are given two-week compound Lactobacillus acidophilus probiotic (1 g t.i.d.), followed by a quadruple antibiotic regimen (esomeprazole [20 mg b.i.d.] + bismuth potassium citrate [220 mg b.i.d.] + tetracycline [750 mg b.i.d.] + furazolidone [100 mg b.i.d.]) for 10 days as rescue therapy.Meanwhile perform endoscopy and take gastric mucosa specimens for gene sequencing before and after the application of probiotic. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 H. pylori eradication failures.
Key exclusion criteria (1 listed)
- Patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.
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 |
|---|---|---|
| Compound Lactobacillus acidophilusAlso: Yi Jun KangCompound Lactobacillus acidophilus Tablet | Other | probiotics and quadruple therapy |
Primary outcome
gene-level changes in the gastric microbiota
Time frame: 2 weeks
study gene-level changes through gene sequencing in the gastric microbiota following use of probiotics
2 secondary outcomes
eradication rate of the therapy
Time frame: 4 weeks
the incidence of the adverse effects
Time frame: 2 weeks, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Individual participant dataSharing planned: Undecided. study protocal
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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.
Yi Qi Du, professor principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound Lactobacillus acidophilus in people with Efficacy and Gastric Microbiota, run by Yiqi Du 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 1 inclusion and 1 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 24 Jun 2019. 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.
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 Yi Qi Du, professor (+8613801993592, duyiqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gene-level changes in the gastric microbiota (time frame: 2 weeks). 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 24 Jun 2019.