The purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora.
Bismuth agent quadruple therapy (including bismuth agent and proton pump inhibitor combined with two antibiotics) is the first-line strategy to eradicate Helicobacter pylori in China. However, it may cause a series of adverse reactions, such as nausea, diarrhea, abdominal pain, constipation, and abnormal taste, etc., which leads to a decrease in patient compliance, thereby affecting the treatment effect. Many studies have found that adding probiotics to traditional Helicobacter pylori eradication therapies increase eradication rates and reduce the side effects of the treatment. Bifidobacterium tetrad live bacteria tablet is a compound microecological preparation composed of bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus. This study aims to observe the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions in Helicobacter pylori quadruple eradication therapy and on the effects of gastrointestinal flora.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
238
On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Probiotic: Bifidobacterium tetrad live bacteria tablets should be taken at noon once a day (30 min after meal ), 9 tablets per time. On day 15-28: Probiotic: Bifidobacterium tetrad live bacteria tablets, taken at noon once a day (30min after meal), 9 tablets per time.
On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Placebo: Bifidobacterium tetrad live bacteria tablet placebos should be taken at noon once a day ( 30 min after meal ), 9 tablets per time. On day 15-28: Placebo: Bifidobacterium tetrad live bacteria tablet placebos, taken at noon once a day (30min after meal), 9 tablets per time.
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGXi'an Central Hospital
Xi’an, Shanxi, China
RECRUITINGthe total incidence rate of digestive tract related adverse reactions
The patient diary cards (including Bristol stool classification, diarrhea, constipation, abdominal pain, abdominal distension, belching, nausea, vomiting, loss of appetite and changes in taste) are filled in daily from the -14th day to 28th day. The above contents are recorded weekly from the 29th to182th day. to calculate the total incidence rate of digestive tract related adverse reactions mentioned above
Time frame: baseline, 28 days, 182days
the incidence rate of various digestive tract related symptoms
to calculate incidence rate of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
Time frame: baseline, 28 days, 182days
duration of various digestive tract related symptoms
to calculate duration of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
Time frame: baseline, 28 days, 182days
stool frequency
to evaluate the defecation frequency of diarrhea and constipation
Time frame: baseline, 28 days, 182days
changes in intestinal flora
to evaluate the changes of intestinal flora during the clinical study period
Time frame: baseline, 14 days, 28 days, 70 days, 182days
changes in gastric flora
20 patients are enrolled in the experiment group and control group respectively. Mucosal samples (one gastric antrum and one gastric body) are taken by gastroscopy before treatment. Gastroscope was reexamined 6 weeks after probiotics or placebo withdrawal (the 70th day), and mucosal samples (one gastric antrum and one gastric body) are taken.
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Time frame: baseline, 70 days
Helicobacter pylori eradication rate
to evaluate the results of 13C-urea breath test
Time frame: 70 days
adverse events
Adverse events are assessed during the clinical study period.
Time frame: 28 days,182 days