GastritisPhase 4NCT03857425
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
A Phase 4 study testing Clostridum Butyricum Capsule, Bacillus Coagulans Tablets and Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets in people with Gastritis and H Pylori Infection, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastritis, H Pylori Infection, Dyspepsia
- What is being tested?
- Clostridum Butyricum Capsule, Bacillus Coagulans Tablets and Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 15 Sep 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- Patients are willing to receive eradication treatment.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Who cannot join
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
- Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma.
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- Underwent upper gastrointestinal Surgery.
- Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Enrolled in other clinical trials in the past 3 months.
- Patients who has psychological problem or poor compliance.
- Refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.
Read the detailed description
The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 8weeks.
Follow-up: includes one visits. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
- Conditions
- Gastritis, H Pylori Infection, Dyspepsia
- Being tested
- Clostridum Butyricum Capsule, Bacillus Coagulans Tablets, Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets
- Keywords
- Gastritis, H Pylori Infection
- Medical subject headings
- Gastritis, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridum Butyricum CapsuleDrug
Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks
Bacillus Coagulans TabletsDrug
Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
Clostridum Butyricum Capsule plus Bacillus Coagulans TabletsDrug
Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Clostridum Butyricum Capsule | Experimental | Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks Receives: Drug: Clostridum Butyricum Capsule |
| Bacillus Coagulans Tablets | Experimental | Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks Receives: Drug: Bacillus Coagulans Tablets |
| Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets | Experimental | Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks Receives: Drug: Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
helicobacter pylori eradication H.pylori eradication
Rate of H.pylori eradication Assessed by urea breath test，rapid urease test or helicobacter pylori stool antigen test after the end of treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Aug 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857425
- Sponsor's protocol ID
- KY20192009-F-1
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Guo J, Li D, Chen M, Liu J, Feng C, He Q, Zhao J, Zhang L, Chen J, Shi Y. The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study. Medicine (Baltimore). 2020 Nov 6;99(45):e22976. doi: 10.1097/MD.0000000000022976.
PubMed 33157939
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets
- ClinicalTrials.gov ID
- NCT03857425
- Acronym / sponsor ID
- KY20192009-F-1
- Conditions
- Gastritis, H Pylori Infection, Dyspepsia
- Keywords
- Gastritis, H Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 28 Feb 2019 (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 aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.
Detailed description
The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 8weeks.
Follow-up: includes one visits. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clostridum Butyricum Capsule | Experimental | Drug: Clostridum Butyricum CapsuleClostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks |
| Bacillus Coagulans Tablets | Experimental | Drug: Bacillus Coagulans TabletsBacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks |
| Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets | Experimental | Drug: Clostridum Butyricum Capsule plus Bacillus Coagulans TabletsClostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- Patients are willing to receive eradication treatment.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Key exclusion criteria (15 listed)
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
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 |
|---|---|---|
| Clostridum Butyricum CapsuleClostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks | Drug | Clostridum Butyricum Capsule |
| Bacillus Coagulans TabletsBacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks | Drug | Bacillus Coagulans Tablets |
| Clostridum Butyricum Capsule plus Bacillus Coagulans TabletsClostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks | Drug | Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets |
Primary outcome
helicobacter pylori eradication H.pylori eradication
Time frame: 8 weeks
Rate of H.pylori eradication Assessed by urea breath test，rapid urease test or helicobacter pylori stool antigen test after the end of treatment.
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 25 Sep 2019.
- Derived from this study: PubMed 33157939Zhang J, Guo J, Li D, Chen M, Liu J, Feng C, He Q, Zhao J, Zhang L, Chen J, Shi Y. The efficacy and safety of Clostridium butyricum and Bacillus coagulans in Helicobacter pylori eradication treatment: An open-label, single-arm pilot study. Medicine (Baltimore). 2020 Nov 6;99(45):e22976. doi: 10.1097/MD.0000000000022976.
- 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.
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 Phase 4 study testing Clostridum Butyricum Capsule, Bacillus Coagulans Tablets and Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets in people with Gastritis and H Pylori Infection, run by Xijing Hospital of Digestive Diseases 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 4 inclusion and 15 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 25 Sep 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.
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?
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?
helicobacter pylori eradication H.pylori eradication (time frame: 8 weeks). 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 NCT03857425, which also lists 1 linked publication.
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 25 Sep 2019.