Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clostridum Butyricum Capsule | Experimental | Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks |
|
| Bacillus Coagulans Tablets | Experimental | Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridum Butyricum Capsule | Drug | Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33157939 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bacillus Coagulans Tablets | Drug | Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks |
|
| Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets | Drug | Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks |
|
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided