Probiotic, Gut Microbiota, Helicobacter Pylori Infection, Insulin Resistance
Conditions
Brief summary
Helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including gastric ulcer and gastric cancer. Recent epidemiological findings have also shown that it is also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin resistance. The aim of this study is to investigate whether the gut microbiota and insulin resistance of patients with H. pylori infection are abnormal. In addition, whether drinking fermented milk product with probiotic reduces Helicobacter pylori, improves gut microbiota, and increases butyrate-producing bacteria and insulin resistance.
Interventions
DIETARY_SUPPLEMENTYogurt
Drink a bottle of 200ml yogurt every morning and evening for 8 weeks
DIETARY_SUPPLEMENTPlacebo
Drink a bottle of 200ml placebo every morning and evening for 8 weeks
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 20 to 70 years old with positive Helicobacter pylori gastric C13 urea breath test (ΔUBT\>10%). 2. Negative gastric Helicobacter (ΔUBT\<2%) matching age, gender, and body mass index.
Exclusion criteria
1. Unhealthy habits or poor health status, including habitual smoking, alcoholism, polypharmacy or drug abuses. 2. Patients with acute diseases, such as respiratory tract infection, acute gastroenteritis. 3. In the past three months, those who have had dyspepsia but have not undergone gastroscopy, or have a history of active gastrointestinal ulcers and gastrointestinal bleeding. 4. Those who have had gastrointestinal cancer or have undergone gastrointestinal surgery. 5. Those who are unwilling to delay receiving Anti-H. pylori therapy. 6. Newly diagnosed cancer (except basal cell carcinoma) or cancer treatment in the past 5 years. 7. People who have had cardiovascular disease, respiratory disease, autoimmune disease, mental disease or other chronic diseases that are not well controlled, such as myocardial infarction or stroke, chronic obstructive pulmonary disease, inflammatory bowel disease, Schizophrenia. 8. Diabetes and those who are or need to take drugs. 9. Those who have used the following drugs in the past month: antibiotics, NSAIDs, obesity drugs, steroid therapy, proton pump inhibitors, bismuth agents. 10. In the past month, regularly consume the following foods (at least 2 times a week): probiotics, prebiotics, or any foods containing probiotics, dairy products (yogurt, cheese), Chinese medicine, kimchi, miso, honey, cranberry, spicy food. 11. Fecal occult blood positive, unexplained iron-deficiency anemia, weight increase or decrease by more than 5% within six months. 12. Abnormal liver function index (AST, ALT or ALP greater than 2 times the upper limit of normal), abnormal renal function index (eGFR less than 45 ml/min). 13. Pregnant or breast-feeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of gut Microbiome | Baseline to day 28 and day 56 | uses high-throughput sequencing to sequence the 16S rRNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of C13 urea breath test | Baseline to day 28 and day 56 | Delta urea breath test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of blood pressure | Baseline to day 28 and day 56 | Change of systolic blood pressure and diastolic blood pressure |
| Change of HOMA-IR | Baseline to day 28 and day 56 | Glucose and insulin will be combined to report HOMA-IR in (mg/dl x mIU/L)/405 |
| Change of high density lipoprotein | Baseline to day 28 and day 56 | Change of high density lipoprotein in the blood |
| Change of weight | Baseline to day 28 and day 56 | weight in kilograms |
| Change of Cholesterol | Baseline to day 28 and day 56 | Change of Cholesterol in the blood |
| Change of Triglyceride | Baseline to day 28 and day 56 | Change of Triglyceride in the blood |
| Change of low density lipoprotein | Baseline to day 28 and day 56 | Change of low density lipoprotein in the blood |
| Change of waist circumference | Baseline to day 28 and day 56 | waist in centimeters |
Countries
Taiwan
Outcome results
None listed