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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Placebo | Placebo Comparator | Adult milk powder 15 g per time, three times daily and half an hour before meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum | Other | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The eighth week of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| The condition of gastrointestinal symptoms in the first week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Bai | Contact | 13925001665 | 13925001665@163.com | |
| Hongying Fan | Contact | 13631381172 | biofhy@126.com |
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The data will be available after August 31, 2025, and will be permanently public.
Everyone
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The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition.
Patients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.
| Bacillus coagulans | Other | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
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| Lactobacillus plantarum + Bacillus coagulans | Other | 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal. |
|
| Placebo | Other | Adult milk powder 15 g pertime, three times daily and half an hour before meal. |
|
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. |
| 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. | 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. | 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. | The fourth week of the trial. |
| ID | Term |
|---|---|
| C562118 | exopolysaccharide biopolymer, Bacillus coagulans |
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