Helicobacter Pylori InfectionNCT05191875
Saccharomyces Boulardii as Pretreatment Before Rescue Therapy of Helicobacter Pylori
A study testing Saccharomyces Boulardii 250 MG and Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Saccharomyces Boulardii 250 MG and Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 23 Apr 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 65 years, of either sex
- patients with a diagnosis of Hp infection
- patients who have failed treatment for Hp infection
- not taking acid-suppressing medications (PPI or H2 blockers) within the last 2 weeks
- who have not used antibiotics and/or bismuth within the last 4 weeks
- understand and are willing to participate in this clinical trial and provide a signed informed consent form.
Who cannot join
- those with a history of drug allergy
- those with severe cardiac, hepatic, pulmonary, and renal insufficiencies
- those with a recent history of gastrointestinal hemorrhage, obstruction, perforation, tumors, and other serious organic diseases of the gastrointestinal tract
- those with mental illness, psychological disorders that cannot be expressed normally
- those who are pregnant, lactating, or planning to have children in the near future during the study period.
- those who are not suitable for clinical trials and those who cannot cooperate
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Gastrointestinal Preparation and Efficacy of Saccharomyces Boulardii as a Pre-treatment for Helicobacter Pylori Rescue Therapy
The increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori) with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the eradication rate, and the secondary outcome was the incidence of adverse events.
Read the detailed description
Background: Helicobacter pylori(H.pylori)infection is a common bacterial infection that causes chronic gastritis, peptic ulcer, MALT lymphoma, gastric cancer, and other gastrointestinal diseases. and has been classified as a group 1 biologic carcinogen with a prevalence of about 50% population in china. In recent years, with the massive use of antibiotics, poor patient compliance, and irregular drug use, the side effects associated with drugs have increased and have led to the development of antibiotic-resistant bacteria and a gradual increase in refractory H.pylori infections, researchers have been searching for a safe, effective and simple treatment for H. pylori.
Methods: The patient come from the department of Gastroenterology, Xiangya Third Hospital, Central South University. After obtaining informed consent, patients is randomly divided into a study group and a control group. The study group (n=100) is divided into two stages of treatment, starting with Saccharomyces boulardii monnotherapy for 14 days, Patients who are still positive on reexamination after 4 weeks of stopping the drug continue with bismuth quadruple therapy. As for the control group (n=100), patients is observed for 4 weeks without any gastric drugs as well as antibiotics, and those who were still positive on retest after 4 weeks continued with bismuth quadruple therapy. We observe the eradication rate of patients and the occurrence of adverse effects during the treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Saccharomyces Boulardii 250 MG, Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate
- Keywords
- Saccharomyces boulardii Helicobacter pylori rescue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces Boulardii 250 MGDrug
Also called treatment drugs of stage I
Saccharomyces Boulardii:
0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory
Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth TartrateDrug
Also called treatment drugs of stage II
Ilaprazole:
5mg*6, produced by Livzon Pharmaceutical Group Inc
Doxycycline:
0.1 g * 10, produced by Jiangsu Yongxin Ltd.
Furazolidone:
0.1g*100 produced by Tianjin Lisheng Pharmaceutical Co., LTD
Colloidal Bismuth Tartrate:
55 mg * 36,produced by Shanxi Xinbaoyuan Pharmaceutical Co., LTD
| Study group | Role | What they receive |
|---|---|---|
| group 1 of stage I | Experimental | 14-day therapy：Saccharomyces boulardii. 500mg b.i.d Receives: Drug: Saccharomyces Boulardii 250 MG |
| group 2 of stage I | No intervention | Observe for one month before treatment |
| stage 2 | Other | 14-day therapy：Ilaprazole. 5mg b.i.d Doxycycline. 0.1g b.i.d Furazolidone. 0.1g b.i.d Colloidal Bismuth Tartrate . 220mg b.i.d Receives: Drug: Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H. pylori infection
Evaluated by 13C-urea breath test (13C-UBT), or 14C-urea breath test (14C-UBT).
Measured: Visit period 2 (day 42±3)
Secondary outcomes (1)
Adverse events
Follow-up of patients' adverse reactions by telephone and at the gastroenterology clinic
Measured: Visit period 1 (day 14±1), Visit period 2 (day 28±1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Dec 2021
- Primary completion12 Apr 2022
- Study completion23 Apr 2022
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 The Third Xiangya Hospital of Central South 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
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191875
- Sponsor's protocol ID
- xucanxia
- Status last verified
- Jan 2022
- First submitted
- 26 Dec 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Preparation and Efficacy of Saccharomyces Boulardii as a Pre-treatment for Helicobacter Pylori Rescue Therapy
- ClinicalTrials.gov ID
- NCT05191875
- Acronym / sponsor ID
- xucanxia
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Saccharomyces boulardii Helicobacter pylori rescue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 23 Apr 2022 (actual)
- First posted
- 14 Jan 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 increasing rate of drug resistance in often leads to eradication failure and the need for rescue therapy, and it is of great significance to explore new rescue therapeutic regimens. In this study, we observed the efficacy of rescue treatment of Helicobacter pylori (H.pylori) with Saccharomyces boulardii (S.boulardii) alone. the primary outcome of the trial was the eradication rate, and the secondary outcome was the incidence of adverse events.
Detailed description
Background: Helicobacter pylori(H.pylori)infection is a common bacterial infection that causes chronic gastritis, peptic ulcer, MALT lymphoma, gastric cancer, and other gastrointestinal diseases. and has been classified as a group 1 biologic carcinogen with a prevalence of about 50% population in china. In recent years, with the massive use of antibiotics, poor patient compliance, and irregular drug use, the side effects associated with drugs have increased and have led to the development of antibiotic-resistant bacteria and a gradual increase in refractory H.pylori infections, researchers have been searching for a safe, effective and simple treatment for H. pylori.
Methods: The patient come from the department of Gastroenterology, Xiangya Third Hospital, Central South University. After obtaining informed consent, patients is randomly divided into a study group and a control group. The study group (n=100) is divided into two stages of treatment, starting with Saccharomyces boulardii monnotherapy for 14 days, Patients who are still positive on reexamination after 4 weeks of stopping the drug continue with bismuth quadruple therapy. As for the control group (n=100), patients is observed for 4 weeks without any gastric drugs as well as antibiotics, and those who were still positive on retest after 4 weeks continued with bismuth quadruple therapy. We observe the eradication rate of patients and the occurrence of adverse effects during the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 of stage I | Experimental | Drug: Saccharomyces Boulardii 250 MG14-day therapy：Saccharomyces boulardii. 500mg b.i.d |
| group 2 of stage I | No intervention | –Observe for one month before treatment |
| stage 2 | Other | Drug: Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate14-day therapy：Ilaprazole. 5mg b.i.d Doxycycline. 0.1g b.i.d Furazolidone. 0.1g b.i.d Colloidal Bismuth Tartrate . 220mg b.i.d |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 to 65 years, of either sex
- patients with a diagnosis of Hp infection
- patients who have failed treatment for Hp infection
- not taking acid-suppressing medications (PPI or H2 blockers) within the last 2 weeks
- who have not used antibiotics and/or bismuth within the last 4 weeks
Key exclusion criteria (6 listed)
- those with a history of drug allergy
- those with severe cardiac, hepatic, pulmonary, and renal insufficiencies
- those with a recent history of gastrointestinal hemorrhage, obstruction, perforation, tumors, and other serious organic diseases of the gastrointestinal tract
- those with mental illness, psychological disorders that cannot be expressed normally
- those who are pregnant, lactating, or planning to have children in the near future during the study period.
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 |
|---|---|---|
| Saccharomyces Boulardii 250 MGAlso: treatment drugs of stage ISaccharomyces Boulardii: 0.25 g * 6, Produced by The French encyclopedia pharmaceutical Factory | Drug | group 1 of stage I |
| Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth TartrateAlso: treatment drugs of stage IIIlaprazole: 5mg*6, produced by Livzon Pharmaceutical Group Inc Doxycycline: 0.1 g * 10, produced by Jiangsu Yongxin Ltd. Furazolidone: 0.1g*100 produced by Tianjin Lisheng Pharmaceutical Co., LTD Colloidal Bismuth Tartrate: 55 mg * 36,produced by Shanxi Xinbaoyuan Pharmaceutical Co., LTD | Drug | stage 2 |
Primary outcome
The eradication rate of H. pylori infection
Time frame: Visit period 2 (day 42±3)
Evaluated by 13C-urea breath test (13C-UBT), or 14C-urea breath test (14C-UBT).
1 secondary outcome
Adverse events
Time frame: Visit period 1 (day 14±1), Visit period 2 (day 28±1)
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 24 May 2022.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces Boulardii 250 MG and Ilaprazole.Doxycycline. Furazolidone. Colloidal Bismuth Tartrate in people with Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University 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 6 inclusion and 6 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 24 May 2022. 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?
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?
The eradication rate of H. pylori infection (time frame: Visit period 2 (day 42±3)). 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 May 2022.