Helicobacter pylori infection
Conditions
Interventions
Gastric microbiome transplantation group:Gastric microbiota transplantation
Second-line anti-Helicobacter pylori treatment group:Omeprazole 20mg twice a day+Levofloxacin 500mg once a day+Amoxicillin 1g twice a day for 14 days
Second-line anti-Helicobacter pylori therapy combined with gastric microbiome transplantation group:Omeprazole 20mg twice a day+Levofloxacin 500mg once a day+Amoxicillin 1g twice a day for 14 days com
Sponsors
The first affiliated Hospital of Chengdu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects included: 1) 18-65 years old, both male and female; 2) patients with chronic atrophic gastritis who failed first-line anti-Hp treatment; 3) outpatients or inpatients who needed gastroscopy; 4) no antibiotics or other drugs, no special diet (diabetes diet, vegetarian diet, low-salt and low-fat diet, etc.) and maintained a normal life (no extra stress) for at least 3 months. 5) at least 3 months from any treatment; 6) before colonoscopy (or other examinations requiring intestinal clearance) or at least 2 weeks before colonoscopy (or other examinations requiring intestinal clearance). 7) No infectious diseases (screening for human immunodeficiency virus, human T-lymphocyte lymphotropic virus, hepatitis A, B and C, cytomegalovirus (CMV), EB virus (EBV), Angiostrongylus, amoebiasis and lupus); 8) all patients signed informed consent forms. Donor inclusion criteria: 1) healthy young people, aged between 18 and 28, regardless of gender; 2) no smoking, alcoholism and other bad habits; 3) the results of stool transplant donor information questionnaire are qualified; 4) the standard scores of self-rating depression scale and self-rating anxiety scale are less than 50; 5) BMI is between 18.5~23.9Kg/m2, physical examination is normal; 6) the results of laboratory examination items are normal.
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects: 1) patients less than 18 years old or more than 65 years old; 2) patients with active upper gastrointestinal bleeding, pyloric obstruction and esophageal stricture; 3) patients with history of esophageal and gastric surgery; 4) patients with severe cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, mental illness and inability to cooperate with examination; 5) patients with poor treatment compliance; 6) patients who are unwilling to take streptomycin. 7) conditions considered unsuitable for selection after evaluation by research physicians / examiners; 8) patients during pregnancy or lactation; 9) allergies to drugs used in this study; 10) withdrawal from the study or loss of follow-up. Donor exclusion criteria: 1) have a history of syphilis, viral hepatitis, acquired immunodeficiency syndrome, tuberculosis, malaria and other known infectious diseases; 2) have uncured infectious diseases; 3) have a history of drug abuse or drug use; 4) have a history of high-risk sexual behavior (Ye you, unstable sexual partners, sexual partners have a history of infection); 5) previous transplant operations. 6) used blood products (whole blood, component blood, human blood protein, etc.) in the past 1 year; 7) used antibiotics, proton pump inhibitors and bismuth in the past 6 months; 8) had a history of skin injuries such as tattoos, acupuncture and puncture in the past 6 months; 9) received medical treatment in poor sanitary conditions in the past 6 months; 10) visited infectious disease areas in the past 6 months; 11) infectious diarrhea occurred in the past 6 months. 12) Live attenuated vaccine in recent 6 months; 13) exposure to multiple drug-resistant bacterial infections in recent 6 months; 14) contact with wild animals in recent 6 months; 15) hematochezia or diarrhea in recent 3 months; 16) use of laxatives, probiotics, immunosuppressants and chemotherapeutic drugs in recent 3 months. 17) previous or present Hp infection, chronic gastric disease, irritable bowel syndrome, inflammatory bowel disease, celiac disease, chronic constipation and other chronic digestive diseases; 18) past history of autoimmune diseases; 19) cancer or gastrointestinal polyposis; 20) neurological or mental diseases (such as multiple sclerosis, autism, depression, schizophrenia, etc.); 21) metabolic diseases (such as diabetes, etc.). 22) suffer from food allergies or other serious allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric mucous layer microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological biopsy;Endoscopic diagnosis;Incidence of adverse reactions;Helicobacter pylori eradication rate;Remission of clinical symptoms; | — |
Countries
China
Contacts
Public ContactLi Jun
The first affiliated Hospital of Chengdu Medical College
Outcome results
None listed