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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yogurt | Experimental | Drink a bottle of 200ml yogurt every morning and evening for 8 weeks |
|
| Placebo | Placebo Comparator | Drink a bottle of 200ml placebo every morning and evening for 8 weeks |
|
| Healthy volunteer | No Intervention | Patients with Helicobacter pylori negative (ΔUBT<2%) need blood test and collect stool samples at first, and collect stool samples again after 2 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt | Dietary Supplement | Drink a bottle of 200ml yogurt every morning and evening for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of gut Microbiome | uses high-throughput sequencing to sequence the 16S rRNA | Baseline to day 28 and day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of C13 urea breath test | Delta urea breath test | Baseline to day 28 and day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of weight | weight in kilograms | Baseline to day 28 and day 56 |
| Change of waist circumference | waist in centimeters | Baseline to day 28 and day 56 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Chung Lien, MDPHD | Taichung Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19457415 | Result | Cover TL, Blaser MJ. Helicobacter pylori in health and disease. Gastroenterology. 2009 May;136(6):1863-73. doi: 10.1053/j.gastro.2009.01.073. Epub 2009 May 7. | |
| 29504247 | Result | Sugizaki K, Tari A, Kitadai Y, Oda I, Nakamura S, Yoshino T, Sugiyama T. Anti-Helicobacter pylori therapy in localized gastric mucosa-associated lymphoid tissue lymphoma: A prospective, nationwide, multicenter study in Japan. Helicobacter. 2018 Apr;23(2):e12474. doi: 10.1111/hel.12474. Epub 2018 Mar 4. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
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| Placebo |
| Dietary Supplement |
Drink a bottle of 200ml placebo every morning and evening for 8 weeks |
|
| Change of blood pressure | Change of systolic blood pressure and diastolic blood pressure | Baseline to day 28 and day 56 |
| Change of HOMA-IR | Glucose and insulin will be combined to report HOMA-IR in (mg/dl x mIU/L)/405 | Baseline to day 28 and day 56 |
| Change of high density lipoprotein | Change of high density lipoprotein in the blood | Baseline to day 28 and day 56 |
| Change of low density lipoprotein | Change of low density lipoprotein in the blood | Baseline to day 28 and day 56 |
| Change of Cholesterol | Change of Cholesterol in the blood | Baseline to day 28 and day 56 |
| Change of Triglyceride | Change of Triglyceride in the blood | Baseline to day 28 and day 56 |
| 30296434 | Result | Butt J, Varga MG, Blot WJ, Teras L, Visvanathan K, Le Marchand L, Haiman C, Chen Y, Bao Y, Sesso HD, Wassertheil-Smoller S, Ho GYF, Tinker LE, Peek RM, Potter JD, Cover TL, Hendrix LH, Huang LC, Hyslop T, Um C, Grodstein F, Song M, Zeleniuch-Jacquotte A, Berndt S, Hildesheim A, Waterboer T, Pawlita M, Epplein M. Serologic Response to Helicobacter pylori Proteins Associated With Risk of Colorectal Cancer Among Diverse Populations in the United States. Gastroenterology. 2019 Jan;156(1):175-186.e2. doi: 10.1053/j.gastro.2018.09.054. Epub 2018 Oct 6. |
| 29600573 | Result | Park H, Park JJ, Park YM, Baik SJ, Lee HJ, Jung DH, Kim JH, Youn YH, Park H. The association between Helicobacter pylori infection and the risk of advanced colorectal neoplasia may differ according to age and cigarette smoking. Helicobacter. 2018 Jun;23(3):e12477. doi: 10.1111/hel.12477. Epub 2018 Mar 29. |
| 25582223 | Result | Chen TP, Hung HF, Chen MK, Lai HH, Hsu WF, Huang KC, Yang KC. Helicobacter Pylori Infection is Positively Associated with Metabolic Syndrome in Taiwanese Adults: a Cross-Sectional Study. Helicobacter. 2015 Jun;20(3):184-91. doi: 10.1111/hel.12190. Epub 2015 Jan 12. |
| D010829 |
| Physiological Phenomena |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |