Helicobacter Pylori Infection
Conditions
Keywords
Gastric Probiotics, Side-effect, Eradication rate, Helicobacter pylori
Brief summary
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.
Detailed description
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.
Interventions
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
OTHERBacillus coagulans
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
OTHERLactobacillus plantarum + Bacillus coagulans
1.5×10\^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
OTHERPlacebo
Adult milk powder 15 g pertime, three times daily and half an hour before meal.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-75 years. * Diagnosed by 13C-UBT within 2 weeks before entry.
Exclusion criteria
* Previous treatment for H. pylori infection. * Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before. * Previous history of gastrointestinal surgery. * Severe or unstable diseases. * Pregnancy or lactation. * Alcoholics and drug abusers. * Staff of this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of Helicobacter pylori | The eighth week of the trial | All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The condition of gastrointestinal symptoms before the trial | Baseline | 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. |
| The condition of gastrointestinal symptoms in the first week | The first week of the trial. | 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 condition of gastrointestinal symptoms in the second week | The second week of the trial. | 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 condition of gastrointestinal symptoms in the third week | The third week of the trial. | 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 condition of gastrointestinal symptoms in the fourth week | The fourth week of the trial. | We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms at the fourth week of this trial. |
Contacts
Primary ContactYang Bai
Backup ContactHongying Fan
Outcome results
None listed